Novation 130-28-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10885862022059), received between Nov 19, 2019 and Jun 2, 2025 — classified as 19 injuries.

The most frequently reported specific device problem is “Naturally Worn” (19 reports).

2 FDA recall records name this device's identifier, 2 still open.

6 other recalls cover devices cleared under the same FDA submission (K100269); 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 18, 2026.

Recalls naming this device

1. Aug 11, 2022Class IIOpen, Classified

   Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

   Z-1731-2022 · Root cause: Process control · Recall details · FDA record ↗

2. Jun 29, 2021Class IIOpen, Classified

   Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

   Z-2116-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, APPROXIMATELY 5.5 YEARS POST THE INITIAL LEFT TOTAL HIP ARTHROPLASTY, THE PATIENT COMPLAINED OF HIP PAIN. THE SURGEON DIAGNOSED WEAR OR DAMAGE OF THE LINER AND REVISION SURGERY TO REPLACE THE LINER AND FEMORAL HEAD WAS PERFORMED. BREAKAGE ON THE RIM OF THE LINER WAS OBSERVED. THE SURGEON DECIDED THERE WAS NO LOOSENING OF THE ACETABULAR CUP AND FEMORAL STEM TO BONE. THE LINER AND FEMORAL HEAD WERE REPLACED TO AN XLE LINER AND DELTA HEAD WITH ADAPTOR. THE POLYETHYLENE PARTICLES ON THE SURGICAL FIELD WERE RESECTED BY THE SURGEON APPROPRIATELY. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 22123561 ↗
• InjuryAug 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 169 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Pain

  MAUDE report 20065514 ↗
• InjuryJul 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 79 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, WEAR AND DELAMINATION OF THE ACETABULAR LINER, AND A SMALL OSTEOLITIC LESION IN THE SUPERIOR ACETABULUM. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bursitis; Inflammation; Osteolysis; Scar Tissue

  MAUDE report 19646740 ↗
• InjuryJun 24, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 134 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. INITIAL SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19601162 ↗
• InjuryJun 24, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 122 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, CATASTROPHIC POLY WEAR, THE POLY HAD BEEN WORN ALL THE WAY THROUGH AND CERAMIC/TITANIUM INTERFACE WAS MAKING AUDIBLE NOISE IN ADDITION TO PAIN. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Pain; Scar Tissue

  MAUDE report 19597333 ↗
• InjuryApr 26, 2024Naturally Worn; Naturally Worn

  THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19191899 ↗
• InjuryMar 19, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 6 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT HIP REVISION ON (B)(6) 2022. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESU

  Patient problems: Insufficient Information

  MAUDE report 18928441 ↗
• InjuryMar 15, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY SEVEN YEARS POST INITIAL LEFT THA, THE 72 Y/O FEMALE PATIENT WAS BROUGHT BACK FOR LEFT HIP PAIN. THE FEMUR WAS DISLOCATED, FEMORAL HEAD REMOVED, STEM WAS WELL FIXED. ATTENTION TURNED TO THE CUP. THE LINER WAS REMOVED WITH THE USE OF A BONE SCREW. THE ACETABULAR SCREW WAS REMOVED, CUP CHECKED AND FOUND TO BE WELL FIXED. THE PATIENT RECEIVED A GROUP 0 XLE LIPPED LINER WITH A 28 + 3.5 HEAD. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS RECEIVED. SALES REP WAS UNABLE TO OBTAIN PHOTOS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO PATIENT REQUESTED IMPLANTS.

  Patient problems: Implant Pain

  MAUDE report 18912415 ↗
• InjuryOct 11, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT RECEIVED A RIGHT TOTAL HIP ARTHROPLASTY ON 25 MAR 2019, AND THEN APPROXIMATELY 4 YEARS, 5 MONTHS LATER ON 6 SEP 2023 HAD A SURGICAL PROCEDURE TO REPLACE THE LINER WITH ANOTHER EXACTECH DEVICE. THE PATIENT COMPLAINS OF PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED MOBILITY AND QUALITY OF LIFE. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. NO IMAGES OR PHOTOS OF THE DEVICE ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Muscle Weakness/Atrophy; Pain

  MAUDE report 17911719 ↗
• InjuryOct 9, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 6 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT HIP REVISION ON (B)(6) 2023. THE PATIENT HAS EXPERIENCED GAIT DISTURBANCE, AND IMPAIRED MOBILITY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Insufficient Information; Osteolysis; Pain

  MAUDE report 17894695 ↗
• InjuryAug 3, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6)2022. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17453034 ↗
• InjuryMay 22, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AND INITIAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2016 AND THEN SHE HAD THE RIGHT HIP REVISED ON (B)(6) 2022. THE REVISION SURGERY WAS APPROXIMATELY 5 YEARS, 8 MONTHS AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT FOR FAILED RIGHT TOTAL HIP REPLACEMENT, REVISION OF THE ACETABULAR COMPONENT. A 71 YO FEMALE WITH A LONG HISTORY OF RIGHT HIP PAIN; COMPLAINED OF CONSTANT GROIN PAIN WORSE WITH WEIGHT BEARING. X-RAYS SHOWED A CUP THAT APPEARED TO HAVE A SIGNIFICANT AREA OF WEAR AND EARLY OSTEOLYSIS. THE STEM APPEARED WELL FIXED. SHE HAD A WORKUP FOR INFECTION THAT WAS NEGATIVE. PROCEDURE: THE BALL HEAD WAS REMOVED FROM THE TRUNNION WHICH WAS INSPECTED AND FOUND TO BE IN EXCELLENT CONDITION. THE FEMUR WAS THE ASSESSED AND FOUND TO BE WELL FIXED AND WELL POSITIONED. THERE WAS BONY INGROWTH AROUND THE CUP. STERILE DRESSING WAS APPLIED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PROCEDURE WAS TOLERATED WELL AND THERE WERE NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT PLAN: DISCHARGE HOME WITH HOME HEALTH AND FOLLOW-UP FOR POST OP CHECK AT 6 WEEKS.

  Patient problems: Implant Pain; Pain

  MAUDE report 16978231 ↗
• InjuryApr 20, 2023Naturally Worn; Naturally Worn

  PER A REPORT FROM THE LEGAL DEPARTMENT THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 3 YEARS AND 3 MONTHS AFTER THE INITIAL SURGERY THE PATIENT HAD A RIGHT HIP REVISION ON (B)(6) 2019 DUE TO A FAILED RIGHT HIP ARTHROPLASTY WITH ECCENTRIC POLYETHYLENE WEAR AND OSTEOLYSIS. THE DOCTOR NOTED IN THE REVISION OPERATIVE REPORT THAT "...DID A COMPLETE SYNOVECTOMY OF THE HIP JOINT DUE TO EXTREME SYNOVITIS AND MELLOSIS. AS I WAS DOING THIS, I NOTICED THAT THE CUP MOVED FORWARD AND THERE WAS EXTREME POLYETHYLENE FAILURE AND WEAR OF THE POLY." THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Metal Related Pathology; Osteolysis; Synovitis

  MAUDE report 16777219 ↗
• InjuryDec 15, 2022Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  AS REPORTED BY LEGAL BRIEF, ON OR ABOUT (B)(6) 2018, PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY DUE TO SEVERE OSTEOARTHRITIS IN HER RIGHT HIP. ORTHOPEDIC SURGEON UTILIZED EXACTECH PRODUCTS IN PATIENT RIGHT HIP AND DID NOT BREACH ANY GENERALLY ACCEPTED STANDARD OF CARE IN THE FIELD OF ORTHOPEDIC SURGERY IN HIS CARE AND TREATMENT OF PATIENT NEGLIGENTLY CAUSE ANY INJURY TO HER. DURING THE SURGERY ON OR ABOUT NOVEMBER 28, 2018, PATIENT HAD AN EXACTECH NOVATION CROWN CUP SYSTEM IMPLANTED IN HER RIGHT HIP, WHICH INCLUDED THE FOLLOWING EXACTECH COMPONENTS (HEREINAFTER "THE DEVICE"): (1) 48 MM NOVATION CROWN CUP; (2) 28 MM NOVATION GXL LINER; (3) 28 MM BIOLOX DELTA FEMORAL HEAD; AND (4) SIZE 1 ALTEON TAPERED WEDGE FEMORAL STEM. AT THE TIME OF IMPLANT, EACH OF THE EXACTECH COMPONENTS OF PATIENT'S RIGHT HIP WAS IN SUBSTANTIALLY THE SAME CONDITION IN ALL RELEVANT RESPECTS AS WHEN THEY LEFT DEFENDANTS' CONTROL. ON OR ABOUT (B)(6) 2022, PATIENT UNDERWENT RIGHT HIP REVISION SURGERY DUE TO RIGHT TOTAL HIP DISLOCATION AND POLYETHYLENE WEAR. SURGEON NOTED IN THE REVISION OPERATIVE REPORT THAT "WITH THE HIP REDUCED ON FLUORO WITH A NON-WEIGHTBEARING FILM, YOU COULD STILL APPRECIATE A SLIGHT ECCENTRI

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 15988898 ↗
• InjuryJun 22, 2022Naturally Worn; Naturally Worn

  AS REPORTED BY THE LEGAL BRIEF, THE FEMALE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY SURGICAL PROCEDURE ON (B)(6) 2013. PATIENT HAD A REVISION SURGERY PERFORMED ON (B)(6) 2020 DUE TO "CATASTROPHIC POLY WEAR" AND "METALLOSIS."

  Patient problems: Failure of Implant

  MAUDE report 14781731 ↗
• InjuryFeb 28, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL LEFT SIDE THA, THIS FEMALE PATIENT WAS BROUGHT BACK WITH LEFT HIP PAIN AND SIGNS OF OSTEOLYSIS. THE FEMORAL HEAD WAS REMOVED, THE STEM WAS WELL FIXED, THE ACETABULAR LINER WAS REMOVED WITH THE USE OF A BONE SCREW, THE CUP WAS CHECKED AND FOUND TO BE WELL FIXED. A NEW G 0 28MM LIPPED XLE LINER WAS IMPLANTED. A NEW FEMORAL HEAD WAS PLACED AND HIP WAS REDUCED. THERE WAS NO BREAKAGE TO DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS ATTACHED. THE DEVICES WILL BE RETURN.

  Patient problems: Osteolysis

  MAUDE report 13623402 ↗
• InjuryNov 29, 2021Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6.5 YRS AFTER THE INITIAL THA, THIS (B)(6) Y/O MALE PATIENT HAD A SURGICAL REVISION DUE TO POLYETHYLENE WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED. PATIENT SUFFERS WITH LONG TERM EFFECTS OF PERTHES' DISEASE.

  Patient problems: Failure of Implant

  MAUDE report 12883942 ↗
• InjuryNov 1, 2021Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YRS POSTOP THE INITIAL RTHA, THE FEMALE PATIENT WAS REVISED, DUE TO OVERTIME THE POLY WORE SIGNIFICANTLY BY REMOVING OUR CUP AND LINER. THE SURGEON BELIEVED THE INSTABILITY OF THE HIP MAY HAVE CAUSED CUP LOOSENING. OVERTIME THE POLY WORE SIGNIFICANTLY. THE ACETABULUM WAS REVISED WITH COMPETITOR IMPLANTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, SENT TO LAB.

  Patient problems: Failure of Implant

  MAUDE report 12731900 ↗
• InjuryNov 19, 2019Naturally Worn

  PREMATURE WEAR OF POLYETHYLENE.

  Patient problems: Bursitis; Cyst(s); Failure of Implant; Muscle/Tendon Damage; No Code Available

  MAUDE report 9342982 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100269. One submission often covers many models, so check the product and lot details in each record.

• Z-2130-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm ID. Orthopedic hip implant com
• Z-2115-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Liner, G00, 22mm ID. Orthopedic hip implant co
• Z-2120-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant
• Z-2125-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-22-XX, Novation GXL Liner, +5mm Lateralized, G00, 22mm ID. Orthopedic hip
• Z-2131-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Line
• Z-2121-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID;