Equinoxe 320-42-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 10885862086693), received between Jun 27, 2019 and Sep 21, 2026 — classified as 107 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (29 reports).

3 FDA recall records name this device's identifier, 3 still open.

10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Aug 15, 2025Open, Classified

   Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

   Z-2561-2025 · Root cause: Process design · Recall details · FDA record ↗

2. 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-1422-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Nov 21, 2023Open, Classified

   Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

   Z-0579-2024 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Insufficient Device Problem Information

  As reported, the patient underwent an initial right reverse total shoulder arthroplasty. Subsequently, the patient was revised due to poly failure. The tray, liner, and glenosphere were swapped. The stem and baseplate were well fixed. 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 50837791 ↗
• InjurySep 8, 2026Device Dislodged or Dislocated

  It was reported that this patient underwent a left shoulder replacement. Subsequently, the patient experienced pain. Upon evaluation, the polyethylene component was found to be dislodged. The patient underwent revision surgery to address the dislodged polyethylene component. The patient was last known to be in stable condition following the event. No further information is available.

  Patient problems: Pain

  MAUDE report 50670302 ↗
• InjuryApr 30, 2026Detachment of Device or Device Component

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 7 YEARS AND 10 MONTHS POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO POLY DISASSOCIATION FROM TRAY. NO TRAUMA NOTED; WOKE UP WITH SHARP PAIN. THE OUTCOME IS CONSIDERED TO BE RESOLVED.

  Patient problems: Pain

  MAUDE report 25046388 ↗
• InjuryMar 13, 2026Unstable

  AS REPORTED, APPROXIMATELY 2 YEARS AND 9 MONTHS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO INSTABILITY. THE SURGEON EXTRACTED THE STANDARD 42MM HUMERAL LINER AND REPLACED IT WITH A 42MM +2.5MMM HUMERAL LINER. 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: Joint Laxity

  MAUDE report 24590990 ↗
• InjuryFeb 26, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A LEFT RTSA, UNDERWENT A REVISION PROCEDURE. THE PATIENT HAD MULTIPLE DISLOCATIONS. THEY WERE REVISED TO A CONSTRAINED LINER. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Joint Dislocation

  MAUDE report 24464515 ↗
• InjuryFeb 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE HUMERAL LINER DISASSOCIATED FROM THE HUMERAL TRAY WHICH RESULTED IN WEAR OF THE GLENOSPHERE AND HUMERAL TRAY. AS A RESULT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION APPROXIMATELY 1 YEAR AND 11 MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Metal Related Pathology

  MAUDE report 24304281 ↗
• InjuryJan 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER ARTHROPLASTY ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO POLY DISASSOCIATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24009060 ↗
• InjuryDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, APPROXIMATELY 2 YEARS AND 7 MONTHS POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO POLY DISASSOCIATION. 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: Pain

  MAUDE report 23907136 ↗
• InjuryDec 15, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT AN 80 YO MALE PATIENT, WHO HAD AN INITIAL RIGHT TSA, UNDERWENT A REVISION PROCEDURE, APPROXIMATELY 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT COMPLAINED OF PAIN. THE IMPLANT DISASSOCIATED. THE LINER WAS REPLACED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES REPORTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT IS NOT BEING RETURNED DUE TO THE HOSPITAL IS UNABLE TO RELEASE WITHOUT PATIENT APPROVAL. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 23812531 ↗
• InjuryNov 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED DISASSOCIATION OF THE POLYETHYLENE COMPONENT - PATIENT WAS PULLING NAILS OUT OF A PIECE OF BOARD AND THE SHOULDER LOCKED. AS A RESULT, APPROXIMATELY 2.5 YEARS 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 locking

  MAUDE report 23524563 ↗
• InjurySep 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REVISION ON THE LEFT SIDE. APPROXIMATELY TWO MONTHS POST-SURGERY, THE PATIENT UNDERWENT A SECOND REVISION FOR AN UNKNOWN REASON. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23034782 ↗
• InjuryAug 20, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED APPROXIMATELY FIVE (5) YEARS AFTER A LEFT REVERSE TOTAL SHOULDER REPLACEMENT SURGERY, A PATIENT UNDERWENT A REVISION PROCEDURE OF THE HUMERAL TRAY, LINER AND HUMERAL STEM. X-RAYS AND IMAGES WERE PROVIDED. OBSERVATIONS OF THE TRAY AND LINER NOTED THE TORQUE SCREW WAS INTACT BETWEEN THE LINER AND THE TRAY BUT THERE WAS NO SCREW THREADS LEFT. THERE WAS NO SCREW OBSERVED ON X RAY, AND NO METALLOSIS OBSERVED. IT WAS REPORTED THE SURGEON COULD NOT FIND THE THREADED PART OF THE BREAK OFF SCREW ANYWHERE IN THE STEM OR THE PATIENT. THE HUMERAL LINER WAS NOTED TO HAVE MINIMAL WEAR. THERE WERE NO SURGICAL DELAYS OR PROLONGATION. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22854603 ↗
• InjuryJul 21, 2025Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 2 YEARS AND 2 MONTHS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO A LOOSE GLENOID COMPONENT WITH MARKED OSTEOLYSIS OF THE GLENOID DUE TO POLYETHYLENE WEAR. EVERYTHING WAS REMOVED. 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: Osteolysis; Unspecified Infection

  MAUDE report 22559630 ↗
• InjuryJun 9, 2025Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT NOTICED THE SHOULDER FELT DIFFERENT IN THE PAST MONTH. IT IS UNKNOWN IF THE PATIENT EXPERIENCED AN INJURY OR FALL PRIOR. IMAGING REVEALED THE HUMERAL LINER HAD DISSOCIATED AND WAS NO LONGER SITTING IN THE TRAY. THE SHOULDER WAS STILL REDUCED, WITH THE TRAY ARTICULATING WITH THE GLENOSPHERE. IT IS UNKNOWN HOW LONG THE HUMERAL LINER HAD BEEN DISSOCIATED. AS A RESULT, APPROXIMATELY 5 YEARS AND 6 MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. THE HUMERAL STEM WAS FOUND TO BE WELL FIXED AND WAS RETAINED. THE HUMERAL LINER HAD MIGRATED POSTERIOR TO THE GLENOSPHERE, AS DISCOVERED FOLLOWING REMOVAL OF THE GLENOSPHERE. THE AREA WAS EXTENSIVELY DEBRIDED AND IRRIGATED WITH ANTIMICROBIAL WOUND SOLUTION AND SALINE. TISSUE CULTURES WERE TAKEN DUE TO OBSERVATION OF METALLOSIS, THERE WAS NO EVIDENCE OF INFECTION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 3 FOR THIS EVENT/PATIENT.

  Patient problems: Metal Related Pathology

  MAUDE report 22169288 ↗
• InjuryMay 30, 2025Unstable; Device Dislodged or Dislocated; Naturally Worn; Unstable; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S LEFT SHOULDER WAS REVISED APPROXIMATELY 9 YEARS POST INITIAL OPERATION. PATIENT HAD BECOME UNSTABLE AND WAS EXPERIENCING RECURRENT DISLOCATION. WHEN THE SURGEON REMOVED THE HUMERAL LINER, IT WAS EXTREMELY WORN. SURGEON BELIEVES THIS WAS A MAJOR CONTRIBUTING FACTOR TO THE DISLOCATION, AS THERE WAS NO 'LIP' HOLDING THE GLENOSPHERE IN PLACE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22114696 ↗
• InjuryMay 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT'S POLY DISASSOCIATED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22088005 ↗
• InjuryApr 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, APPROXIMATELY 2 YEARS AND 1 MONTH POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO THE POLY BEING DISASSOCIATED. 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 21926345 ↗
• InjuryApr 8, 2025Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION APPROXIMATELY 39 MONTHS AFTER A RIGHT SHOULDER REPLACEMENT SURGERY, THE PATIENT UNDERWENT AN ARTHROSCOPIC LYSIS OF ADHESIONS AND DEBRIDEMENT TO ADDRESS PAINT, STIFFNESS, DISFUNCTION AND TIGHTNESS. THERE WERE SURGICAL OR MEDICAL INTERVENTIONS REPORTED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 21797736 ↗
• InjuryApr 1, 2025Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT WAS COMPLAINING OF A SORE SHOULDER. THE SURGEON WAS REVISING THE GLENOID DUE TO SOME LOOSENING. PATIENT'S GLENOID WAS REVISED TO COMPETITOR'S DEVICE. THERE WAS NO BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS AND X-RAYS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO RESIDENT WANTED TO KEEP THEM. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21739012 ↗
• InjuryMar 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 63 YO MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED IN (B)(6) 2016, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 8 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. ACCORDING TO THE SURGEON, THE PATIENT WAS ON THE PHONE FOR AN EXTENDED PERIOD OF TIME AND THEN FELT SHOULDER PAIN DUE TO A DISSOCIATED POLY. THE PATIENT WAS REVISED TO 145-DEG PE 42MM CONSTRAINED HUMERAL LINER +0MM. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICE WAS NOT AVAILABLE FOR RETURN DUE TO HOSPITAL POLICY. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 21626474 ↗
• InjuryFeb 18, 2025Unstable; Detachment of Device or Device Component; Device Dislodged or Dislocated; Unstable; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS PATIENT'S LEFT SHOULDER WAS REVISED APPROXIMATELY 3 YEARS POST INITIAL OPERATION. SURGEON INDICATED THAT PATIENT¿S SHOULDER HAD BECOME DISLOCATED/UNSTABLE. UPON INTRAOPERATIVE VISUALIZATION, HUMERAL LINER WAS FOUND TO BE DISSOCIATED FROM HUMERAL ADAPTER TRAY. ALL IMPLANTS WERE REMOVED AND REPLACED WITH CORRESPONDING IMPLANTS ASSOCIATED WITH LARGER DIAMETER (46 MM) GLENOSPHERE - E.G., THE GLENOSPHERE, AND THE ASSOCIATED HUMERAL LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 21401980 ↗
• InjuryJan 2, 2025Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  APPROXIMATELY 6 YEAR(S), 11 MONTH(S) POST-OPERATIVE OF A RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED POLYETHYLENE WEAR WITH OR WITHOUT OSTEOLYSIS. ADDITIONALLY, THE PATIENT FELL FROM HIS BIKE IN (B)(6) 2023. THIS DAY IN CONSULTATION: LOSS OF SHOULDER RANGE OF MOTION, AND WEAR OF THE POLYETHYLENE. THE PATIENT UNDERWENT A STANDARD REVERSE REVISION WITH THE REPORTED REMOVAL OF THE HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW COMPONENTS. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THE EVENT IS DEFINITELY NOT 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: Loss of Range of Motion

  MAUDE report 21063481 ↗
• InjuryDec 30, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 74 YO FEMALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED IN (B)(6) 2021, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 3 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT'S RIGHT SHOULDER WAS VERY TENDER AND HAD A SMALL AREA OF GRANULATION AT THE BOTTOM OF THE WOMB, CONSISTENT WITH INFECTION, POSSIBLY DUE TO POLYETHENE WEAR. ALL IMPLANTS WERE REMOVED DUE TO INFECTION. AN ANTIBIOTIC SPACER WAS PLACED. THE 42 +0 HUMERAL LINER THAT WAS IMPLANTED WAS AFFECTED BY THE RECALL, THE POLY DID APPEAR TO HAVE SOME WEAR, BUT IS NOT CERTAIN THAT WAS THE CAUSE OF THE INFECTION. THE PATIENT HAD A FALL ON THE RIGHT SHOULDER IN 2023, BUT IT APPEARED FINE. CULTURES WERE SENT AND THE PATHOLOGY WELL BE PROVIDED TO THE SURGEON. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Granuloma; Medical device site infection; Unspecified Infection

  MAUDE report 21034491 ↗
• InjuryDec 16, 2024Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS POST INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY (TSA), A REVISION WAS PERFORMED DUE TO POLYETHYLENE LINER DISSOCIATION. THE SURGEON REMOVED A 42 GLENOSPHERE, HUMERAL TRAY, LINER AND SCREWS AND REPLACED WITH A 42+4 GLENOSPHERE, +0 HUMERAL TRAY, GLENOSPHERE LOCKING SCREW, REVERSE SHOULDER TORQUE SCREW KIT AND NEW 42+0 LINER. THE EVENT WAS UNRELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20940774 ↗
• InjuryDec 13, 2024Unstable; Detachment of Device or Device Component; Device Dislodged or Dislocated; Unstable; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 4 YEARS AND 3 MONTHS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE LINER DISSOCIATED AND THE PATIENT WAS REVISED. THERE WAS NO TRAUMA EVENT. A NEW GLENOSPHERE, LINER, LOCKING SCREW, AND ADAPTOR TRAY WERE IMPLANTED. ALL FRAGMENTS, PARTS OR PIECES WERE REMOVED. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information; Joint Dislocation; Joint Laxity

  MAUDE report 20924532 ↗

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-1425-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
• Z-1419-2024 · Mar 6, 2024 · Open, Classified
  Exactech 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-1424-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
• Z-1423-2024 · Mar 6, 2024 · Open, Classified
  Exactech 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-1418-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
• Z-3020-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
• Z-3019-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
• Z-0012-2019 · Aug 21, 2018 · Open, Classified
  Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
• Z-0900-2017 · Oct 25, 2016 · Terminated
  Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
• Z-2117-2012 · Jun 15, 2012 · Terminated
  Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.