Equinoxe 320-46-03Recalls & reported problems
Exactech, Inc. · Class 2 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10885862086747), received between May 29, 2019 and Jul 31, 2026 — classified as 23 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 reports).
1 FDA recall record name this device's identifier, 1 still open.
12 other recalls cover devices cleared under the same FDA submission (K063569); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Mar 6, 2024Open, Classified
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Z-1424-2024 · Root cause: Nonconforming Material/Component · FDA record ↗
Most reported problems
Device problems
- Device Dislodged or Dislocated12
- Detachment of Device or Device Component10
- Adverse Event Without Identified Device or Use Problem3
- Naturally Worn2
- Unstable2
- Appropriate Device Problem Term/Code Not Available1
- Inadequacy of Device Shape and/or Size1
- Migration1
Patient problems
- Failure of Implant8
- Joint Dislocation6
- Insufficient Information5
- Joint Laxity2
- Pain2
- Hypersensitivity/Allergic reaction1
- Implant Pain1
- Loss of Range of Motion1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2026Detachment of Device or Device Component
As reported, the patient underwent a reverse total shoulder arthroplasty. Subsequently, the patient was revised due to suspected humeral liner dissociation from the humeral adapter tray. It was confirmed intraoperatively that the patient's humeral liner had dissociated from the humeral adapter tray. There was no reported breakage of a device or surgical delay/prolongation. The patient was last known to be in stable condition following the event.
Patient problems: Insufficient Information
MAUDE report 50101931 ↗InjuryJun 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED A DISLOCATION. THE PATIENT DISLOCATED IN THEIR SLEEP. AS A RESULT, APPROXIMATELY 1 YEAR AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 22202163 ↗InjuryFeb 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED. PATIENT DISASSOCIATED THE POLY FROM THE HUMERAL TRAY. HE DESCRIBED TO THE DR THAT THE EVENT OCCURRED WHILE STRETCHING. PATIENT WAS REIMPLANTED WITH A 46 GLENOSPHERE, +5 HUMERAL ADAPTER TRAY & A 46MM +2.5MM POLY PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Insufficient Information
MAUDE report 21459150 ↗InjuryFeb 11, 2025Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component
APPROXIMATELY 8 YEAR(S), 4 MONTH(S) AND 2 DAY(S) POST-OPERATIVE OF A REVISED RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DISASSOCIATION OF POLYETHYLENE. PATIENT'S SHOULDER 'LOCKED UP' WHILE AT WORK WITH FEELINGS OF INSTABILITY THEREAFTER. THE PATIENT UNDERWENT A TENDON TRANSFER WITH ROTATOR CUFF REPAIR 3 MONTHS POST OPERATIVELY (SEE CASE-(B)(4) AND WAS REVISED APPROXIMATELY 5 MONTHS POST OPERATIVE OF THE INITIAL IMPLANTATION OF DEVICES FOR UNKNOWN REASONS. (SEE CASE-(B)(4) ONE MONTH AND FIVE DAYS FOLLOWING THE ONSET OF SYMPTOMS, THE PATIENT UNDERWENT A STANDARD REVERSE REVISION WITH REPORTED REMOVAL OF THE TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW COMPONENTS. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED, AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND DEFINITELY RELATED TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES, NO DEVICE RETURN IS ANTICIPATED, AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Joint Laxity; Muscle/Tendon Damage
MAUDE report 21358650 ↗InjuryJan 3, 2025Naturally Worn; Naturally Worn
APPROXIMATELY 7 MONTH(S) AND 13 DAY(S) POST-OPERATIVE OF A REVISED RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DISASSOCIATION OF GLENOSPHERE WITH INCREASED PAIN AND SIGNIFICANT POLY WEAR. THE PATIENT WAS PREVIOUSLY REVISED FOR ASEPTIC GLENOID LOOSENING. THE PATIENT UNDERWENT A STANDARD REVERSE WITH PRESERVE STEM REVISION FOR THE DISASSOCIATION WITH THE REPORTED REMOVAL OF THE HUMERAL LINER, GLENOSPHERE, AND GLENOID BASE PLATE COMPONENTS. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES, NO DEVICE RETURN IS ANTICIPATED, AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 21069109 ↗InjuryDec 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
APPROXIMATELY 6 YEAR(S), 1 MONTH(S) AND 29 DAY(S) POST-OPERATIVE OF AN REVISED LEFT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DISASSOCIATION OF POLYETHYLENE DUE TO WORKING OUT WITH RESISTANCE BANDS. IN AN EARLIER EVENT, THE PATIENT EXPERIENCED DISASSOCIATION OF OTHER COMPONENT - DISLOCATION OF MODULAR DEVICE DURING PHYSICAL ACTIVITY THAT WAS RESOLVE BY REVISION AND CAPTURED IN (B)(4). THE PATIENT UNDERWENT ANOTHER STANDARD REVERSE REVISION WITH THE REPORTED REMOVAL OF THE HUMERAL TRAY, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW COMPONENTS. THE HUMERAL LINER WAS NOT REPORTED AS REMOVED IN THE ADVERSE EVENT DESCRIPTION BUT WAS LISTED AS A PRODUCT. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND UNLIKELY RELATED TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 21036193 ↗InjuryOct 2, 2024Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration
IT WAS REPORTED THAT THIS PATIENT HAD A RIGHT REVERSE SHOULDER PUT IN 2020. REVISED AGAIN IN 2021 BY A LOCAL ORTHOPEDIC SURGEON. THEN PATIENT SAW A DIFFERENT SURGEON WHO REVISED THE PATIENT AND TOOK OUT HUMERAL COMPONENTS AND GLENOSPHERE AND REPLACED. THERE WAS A LOT OF MATELLOSIS AND THE TRAY WAS COMPLETELY SHEERED OFF THE STEM. THE STEM HAD OVERSTUFFED THE JOINT, A 15 PRESERVE STEM WAS USED. THE SURGEON COULD NOT FIND THE LINER POLY FROM THE ORIGINAL SURGERY. SURGEON CHECKED AROUND THE JOINT FOR IT AS WELL AS HIS PA AND ASSIST. NO ONE COULD FEEL FOR THE 46 +2.5MM LINER IN THE JOINT. PATIENT WAS REVISED TO A FX STEM AND A NEW GLENOSPHERE AND TRAY AND LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT
Patient problems: Implant Pain; Loss of Range of Motion; Metal Related Pathology
MAUDE report 20351965 ↗InjurySep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THIS 81 Y/O MALE PATIENT'S LEFT SHOULDER WAS REVISED APPROXIMATELY 4 YEARS POST OP. SURGEON REVISED AN EXACTECH REVERSE SHOULDER DUE TO A DISPLACED 46 LINER. HE REMOVED A 46 INSET GLENOSPHERE AND DISPLACED LINER AND REPLACED WITH A 42+4 GLENOSPHERE AND A 42, CONSTRAINED, 135 DEGREE LINER WITH NEW LOCKING MECHANISM.
Patient problems: Insufficient Information
MAUDE report 20239068 ↗InjuryMay 3, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS 64 Y/O MALE PATIENT'S LEFT SHOULDER WAS REVISED APPROXIMATELY 1 YEAR 3 MONTHS POST OP INITIAL SURGERY DUE TO INSTABILITY THEN AGAIN 1 YEAR AFTER THAT SURGERY. PATIENT HAD HIS ORIGINAL CASE DONE (B)(6) 2022 AND WAS REVISED ON (B)(6) 2023 AND AGAIN DURING OUR CASE (B)(6) 2024. DOCTOR REMOVED ALL IMPLANTS AND IMPLANTED ALL NEW IMPLANTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 19244302 ↗InjuryMar 11, 2024Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated
IT WAS REPORTED THAT A 66 YO MALE PATIENT, INITIAL LEFT REVERSE SHOULDER IMPLANTED ON (B)(6) 2023, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. THE PATIENT PRESENTED TO THE SURGEON DUE TO A DISLOCATION. THE SURGEON SCHEDULED A REVISION. DURING THE PROCEDURE, THE SURGEON REMOVED THE LINER AND GLENOSPHERE, AND IMPLANTED A STD 46 GLENOSPHERE AND THEN TRIALED A +0, +2.5, +5 46 LINER AND FOUND THAT THE +5 BUILD UP TO BE THE MOST STABLE. HE IMPLANTED THE FINAL IMPLANTS AND REDUCED THE SHOULDER. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE EVENT. NO X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS. THE HOSPITAL KEPT THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.
Patient problems: Joint Dislocation
MAUDE report 18882331 ↗InjuryMay 9, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Naturally Worn; Detachment of Device or Device Component; Device Dislodged or Dislocated; Naturally Worn
IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER DISLOCATED, POLY DISASSOCIATED. SURGEON REPLACED GLENOSHERE, TRAY AND CONSTRAINED LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Joint Dislocation
MAUDE report 16894143 ↗InjuryOct 4, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT THIS MALE PATIENT PRESENTED WITH A LEFT EXACTECH REVERSE SHOULDER WITH A DISSOCIATED HUMERAL POLY COMPONENT. PATIENT DID NOT REPORT ANY TRAUMATIC EVENT. DISSOCIATED POLY WAS REMOVED ALONG WITH THE ADAPTER TRAY, GLENOSPHERE, AND LOCKING SCREWS FOR EACH. A LATERALIZED GLENOSPHERE WAS IMPLANTED AS WELL AS A +5 TRAY AND +0 LINER. NO ADVERSE EVENT AS A RESULT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 15536718 ↗InjuryMar 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP INITIAL LEFT TSA, THIS (B)(6) PATIENT WAS REVISED DUE TO DISLOCATION OF JOINT WHICH LEAD TO DISLODGING OF THE POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING DUE TO THE HOSPITAL DISPOSING OF THEM.
Patient problems: Joint Dislocation
MAUDE report 13710692 ↗InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, THIS (B)(6) MALE PATIENT'S LEFT SHOULDER HAD INSTABILITY AND NEEDED A REVISION. PATIENT APPEARED TO HAVE SHOULDER "CREEP" AND WAS DISLOCATING WITH INSTABILITY. A REVISION OCCURRED AND A 42 +4 GLENOSPHERE WAS PUT ON WITH A +10 ADAPTOR TRAY AND 42 +0 POLY. PATIENT WAS RELOCATED IN OFFICE AND THEN DISLOCATED AGAIN AND WAS SCHEDULED FOR A REVISION. NO DELAY TO SURGERY. DEVICE WAS THROWN AWAY BY HOSPITAL, UNABLE TO RETRIEVE.
Patient problems: Failure of Implant
MAUDE report 13451248 ↗InjuryOct 18, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE LINER DISASSOCIATED FROM THE HUMERAL TRAY CAUSING THE (B)(6) MALE PATIENT'S SHOULDER TO DISLOCATE. THE SURGEON REVISED THE LEFT SIDE GLENOSPHERE TO A 42+4. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT
Patient problems: Failure of Implant
MAUDE report 12646583 ↗InjuryApr 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
AS REPORTED, APPROXIMATELY 5 WEEKS POSTOP A RIGHT SHOULDER REVISION, THE SURGEON REVISED THE (B)(6) Y/O MALE PATIENT'S RIGHT SHOULDER DUE TO THE LINER SEPARATING FROM THE HUMERAL TRAY SOMETIME AFTER THE PATIENT HAD HIS REVISION SURGERY. DR. (B)(6) REMOVED A 46 GLENOSPHERE, A 46 +2.5 HUMERAL LINER, AN ADAPTOR TRAY AND A PRESERVE STEM. HE REVISED THE GLENOID SIDE WITH A 42 +4MM GLENOSPHERE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING DUE TO FACILITY POLICY.
Patient problems: Failure of Implant
MAUDE report 11695153 ↗InjuryApr 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
AS REPORTED, THIS (B)(6) Y/O MALE PATIENT'S LEFT SHOULDER DISLOCATED SOMETIME AFTER HIS INITIAL SURGERY. THE SURGEON HAD TO REVISE THE PATIENT'S SHOULDER DUE TO THE LINER SEPARATING FROM THE HUMERAL TRAY SOMETIME AFTER INITIAL SURGERY. THE SURGEON REMOVED A 46 INSET GLENOSPHERE, 46 NEUTRAL LINER, +5MM ADAPTER TRAY AND A SIZE 6 PRESERVE STEM. HE REPLACED THEM WITH A 42 +4MM GLENOSPHERE, 42 +2.5 HUMERAL LINER, +5MM ADAPTER TRAY AND A SIZE 10 PRESERVE STEM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO BE RETURNED.
Patient problems: Joint Dislocation
MAUDE report 11618091 ↗InjuryMar 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
AS REPORTED, THIS (B)(6) Y/O MALE PATIENT RIGHT SHOULDER TSA LINER DISASSOCIATED FROM THE HUMERAL TRAY CAUSING THE PATIENT¿S SHOULDER TO DISLOCATE. THIS PATIENT HAS A HISTORY OF DISLOCATING. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO RETURN FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11539597 ↗InjurySep 21, 2020Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2011, THIS MALE PATIENT UNDERWENT IMPLANTATION OF AN EXACTECH REVERSE TOTAL SHOULDER REPLACEMENT. APPROXIMATELY 6 MONTHS LATER, (B)(6)2012, THE PATIENT WAS REVISED TO REMOVE ALL SHOULDER DEVICES CONTAINING METAL TO RESOLVE A NEWLY DIAGNOSED METAL ALLERGY. THE SURGEON DECIDED TO TEMPORARILY IMPLANT DEVICES TO PRESERVE THE SPACE AND THE PATIENT¿S ANATOMY WHILE THE CUSTOM CERAMIC GLENOSPHERE IMPLANT IS BEING MANUFACTURED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 10559625 ↗InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, APPROXIMATELY 4MOS. POSTOP, A (B)(6) Y/O MALE WITH A ¿LARGER FRAME¿ CAME TO THE OR WITH HIS RIGHT SHOULDER DISLOCATED. AFTER TRAILING, THE SURGEON CHOSE TO IMPLANT THE SAME SIZED COMPONENTS THAT WERE REMOVED, WITH EXCEPTION OF UPSIZING THE TRAY. DEVICES WILL NOT BE RETURNED.
Patient problems: Joint Dislocation
MAUDE report 10162544 ↗InjuryJun 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AS REPORTED, APPROXIMATELY 1 YEAR POSTOP OF THE INITIAL SHOULDER IMPLANT, THIS (B)(6) Y/O MALE PATIENT PRESENTED WITH COMPLAINTS OF DECREASED FUNCTION IN ARM/SHOULDER. UPON EXAMINATION, IT WAS DETERMINED THAT THE POLYETHYLENE HAD DISASSOCIATED. A REVISION TO A REVERSE SHOULDER WAS COMPLETED. NO POSTOP PROBLEMS REPORTED. PATIENT HAS HISTORY OF UNDERLYING END-STAGE OSTEOARTHROSIS, HYPERTENSION, HEART DISEASE, HYPERTHYROIDISM, AND HYPERCHOLESTEROLEMIA. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.
Patient problems: Failure of Implant
MAUDE report 10152649 ↗InjuryJun 9, 2020Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
APPROXIMATELY 10 WEEKS POSTOP THE INITIAL LEFT TSA, AN (B)(6) Y/O MALE PATIENT¿S POLY BECAME DISENGAGED IN THE LEFT SHOULDER CAUSING A REVISION. THE SURGEON WANTED TO REVISE THE GLENOSPHERE AS WELL. AS A RESULT, HE ¿REBROKE¿ THE SCREW ON THE TRAY, AND WHEN HE WENT TO DISLODGE THE TRAY FROM THE STEM, THE ENTIRE STEM CAME LOOSE CAUSING A NECESSARY FULL REVISION OF THE HUMERAL SIDE AS WELL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS AVAILABLE FOR RETURN. HUMERAL LOOSENING IS CAPTURED UNDER 1038671-2020-00294.
Patient problems: Failure of Implant; Pain
MAUDE report 10132399 ↗InjuryMay 29, 2019Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
IN 2017 PATIENT HAD A REVERSE LEFT SHOULDER REPLACEMENT WITH EXACTECH COMPONENTS. IN LATE 2018 THE PLASTIC CUP BETWEEN THE TWO METAL ELEMENTS CAME OUT. THE PLASTIC CUP CAME OUT WHILE PATIENT WAS DOING PHYSICAL THERAPY FOR RIGHT SHOULDER TRADITIONAL REPLACEMENT (ALSO EXACTECH COMPONENTS).
Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient
MAUDE report 8649510 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K063569. One submission often covers many models, so check the product and lot details in each record.
- Z-2561-2025 · Aug 15, 2025 · Open, ClassifiedExactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/
- Z-1419-2024 · Mar 6, 2024 · Open, ClassifiedExactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
- Z-1418-2024 · Mar 6, 2024 · Open, ClassifiedExactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
- Z-1423-2024 · Mar 6, 2024 · Open, ClassifiedExactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
- Z-1422-2024 · Mar 6, 2024 · Open, ClassifiedExactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
- Z-1425-2024 · Mar 6, 2024 · Open, ClassifiedExactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
- Z-0579-2024 · Nov 21, 2023 · Open, ClassifiedExactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00,
- Z-3019-2020 · Aug 24, 2020 · TerminatedEquinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
- Z-3020-2020 · Aug 24, 2020 · TerminatedEquinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
- Z-0012-2019 · Aug 21, 2018 · Open, ClassifiedEquinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
- Z-0900-2017 · Oct 25, 2016 · TerminatedEquinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
- Z-2117-2012 · Jun 15, 2012 · TerminatedEquinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Other Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.