OmnifitRecalls & reported problems across all models
Howmedica Osteonics Corp. · 43 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Omnifit model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 61
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls
- 3
We found 43 models of Omnifit by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 61 adverse event reports in the FDA's MAUDE database, received between Jun 26, 2018 and Oct 15, 2025 — classified as 55 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 reports).
3 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Omnifit recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 30, 2026Open, Classified
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.
Z-3201-2026 · Root cause: Process change control · Recall details · FDA record ↗
- Jul 30, 2026Open, Classified
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.
Z-3196-2026 · Root cause: Process change control · Recall details · FDA record ↗
- Nov 7, 2019Terminated
May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire
Z-0811-2020 · Root cause: Employee error · Recall details · FDA record ↗
Most reported Omnifit problems
Device problems
- Device Dislodged or Dislocated10
- Naturally Worn10
- Adverse Event Without Identified Device or Use Problem9
- Insufficient Device Problem Information9
- Degraded5
- Osseointegration Problem5
- Loss of Osseointegration4
- Fracture3
Patient problems
- Injury17
- Joint Dislocation11
- Pain10
- Inadequate Osseointegration9
- Insufficient Information9
- Bone Fracture(s)6
- Ambulation or Postural Difficulties4
- No Clinical Signs, Symptoms or Conditions4
Omnifit models
43 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Omnifit 2041C-3254Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall2 reports
- Omnifit 2001-2246Prosthesis, hip, semi-constrained (metal cemented acetabular component)1 recall0 reports
- Omnifit 61-3258Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall0 reports
- Omnifit 2041C-2846Prosthesis, hip, semi-constrained, metal/polymer, uncemented5 reports
- Omnifit 2041-2850PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- Omnifit 2041-2854PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- Omnifit 2041C-3250PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- Omnifit 2043-2850PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- Omnifit 2041-2858PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- Omnifit 6097-0835Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- Omnifit S-2301C-2846Prosthesis, hip, semi-constrained, metal/polymer, uncemented2 reports
- Omnifit 6070-0730AProsthesis, hip, hemi-, femoral, metal2 reports
- Omnifit 6076-0730AProsthesis, hip, hemi-, femoral, metal2 reports
- Omnifit 6076-0830AProsthesis, hip, semi-constrained, metal/polymer, uncemented2 reports
- Omnifit 6017-0935AProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- Omnifit 2041-2654PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Omnifit 2041C-2658Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- Omnifit 2041C-2858Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Omnifit 2041C-3258Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- Omnifit 2042-2646PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Omnifit 2042-2654PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Omnifit 2042-2858PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Omnifit 2043-2858PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Omnifit 2043C-2846PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Omnifit 2043C-2850PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Omnifit 2043C-2854Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- Omnifit 6041-0625Prosthesis, hip, hemi-, femoral, metal1 report
- Omnifit 6041-0730Prosthesis, hip, hemi-, femoral, metal1 report
- Omnifit 1067-0010Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Omnifit 6088-0525-200RProsthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Omnifit 6088-0525-250RProsthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Omnifit 6097-0630Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Omnifit 6098-0530Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Omnifit 6098-0735Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Omnifit S-2301C-3262Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Omnifit S-2302C-3250PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Omnifit 6070-1035AProsthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Omnifit 6070-0935AProsthesis, hip, hemi-, femoral, metal1 report
- Omnifit 6076-0525AProsthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- Omnifit 2001-2848Prosthesis, hip, semi-constrained (metal cemented acetabular component)1 report
- Omnifit 6017-0525AProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Omnifit 6017-0625AProsthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Omnifit 2041C-2246PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
Recent Omnifit adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO RECURRENT DISLOCATIONS. A HEAD AND LINER EXCHANGE WAS PERFORMED, CONVERTING THE LINER TO A CONSTRAINED LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Joint Dislocation
MAUDE report 23300289 ↗InjuryMay 29, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO ECENTRIC WEAR OF THE LINER. A HEAD AND LINER EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Insufficient Information
MAUDE report 22108596 ↗InjuryNov 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THA PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2003. DISLOCATION WAS CONFIRMED AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. (EVENT#1). THIS PI IS FOR EVENT#1. EVENT#2 (INTRA-OP INSTRUMENT DAMAGE) IS REPORTED IN ANOTHER PI.
Patient problems: Joint Dislocation
MAUDE report 20756130 ↗InjuryJul 22, 2024Loss of Osseointegration; Loss of Osseointegration
ORIGINAL RIGHT HIP REPLACEMENT DONE IN 1998 - ORIGINAL MEDICAL RECORDS NOT AVAILABLE. DR REVISED STEM ONLY OF RIGHT HIP, DUE TO LOOSENING. SURGERY PROCEEDED AS PLANNED, NO DELAY, NO ADVERSE CONSEQUENCES PERTAINING TO PATIENT REPORTED.
Patient problems: Inadequate Osseointegration
MAUDE report 19800631 ↗InjuryMar 18, 2024Fracture; Fracture
PATIENT REPORTED A RIGHT HIP REVISION DUE TO LINER BREAKING. HEAD, CUP AND INSERT REVISED TO A LARGER SIZE.
Patient problems: Insufficient Information; Subluxation
MAUDE report 18921739 ↗InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY STRYKER SALE REP THAT THE PATIENT DID RTHR 2001 UNDER DOCTOR AND CAME TO DOCTOR WITH A FRACTURED PROXIMAL POSTERIOR FEMUR AND REQUESTED A REVISION. SURGERY SCHEDULED ON (B)(6) 2024 HOWEVER, STRYKER SALE REP COULDN'T FIND ANY INFORMATION AND DETAILS OF THE USED IMPLANTS. ONLY DURING INTRA-OP WHILE IMPLANTS WERE EXPLANTED WE COULD CONFIRMED IT WAS STRYKER PRODUCT.
Patient problems: Hip Fracture
MAUDE report 18716632 ↗InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO FRACTURE OF THE TROCHANTER, WHICH LED TO DISLOCATION OF THE BIPOLAR HEAD FROM THE PATIENT'S NATIVE ACETABULUM (SURGEON REPORTED CONTRIBUTING FACTORS: NON-COMPLIANT PATIENT, POOR BONE QUALITY). PATIENT WAS CONVERTED TO A TOTAL HIP (STEM WAS RETAINED). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Bone Fracture(s)
MAUDE report 18222568 ↗InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. AN I&D WAS PERFORMED, A COMPETITOR HEAD WAS REVISED AND A 32MM 10° SERIES II INSERT WAS EXCHANGED FOR ANOTHER ONE.
Patient problems: Unspecified Infection
MAUDE report 17955621 ↗InjuryJun 16, 2023Degraded; Degraded
HOSPITAL REPORTED TO REP THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO ECENTRIC POLY WEAR (REP WAS NOT PRESENT FOR THE PROCEDURE). A HEAD AND LINER WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Insufficient Information
MAUDE report 17141297 ↗InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS PI IS FOR THE FEMORAL STEM AND HEAD. IT WAS REPORTED THAT THE PATIENT'S RIGHT FEMUR WAS REVISED. AFTER A PREVIOUS ORIF TO ADDRESS A FEMORAL FRACTURE, PATIENT PRESENTED COMPLAINING OF PAIN AND LIMITED ROM. X-RAY SHOWED NON-UNION OF THE BONE WITH 3 BROKEN SCREWS AND ONE SCREW WHICH PULLED OUT WITH THE PLATE. A FEMORAL STEM AND HEAD, THE PLATE AND SCREWS, AND A COMPETITOR KNEE WERE REVISED TO A COMPETITOR TOTAL FEMUR REPLACEMENT (ACETABULAR COMPONENTS WERE LEFT IN SITU). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Bone Fracture(s); Loss of Range of Motion; Pain
MAUDE report 17084996 ↗InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER IMPLANTATION OF A RIGHT STRYKER HIP AND COMPETITOR KNEE, THE PATIENT FELL AND SUSTAINED A FEMORAL FRACTURE NEAR THE DISTAL TIP OF THE STEM. NO IMPLANTS WERE REVISED, BUT AN ORIF WAS PERFORMED WITH IMPLANTATION OF A PLATE AND SCREWS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Bone Fracture(s); Fall
MAUDE report 17076308 ↗InjuryMay 26, 2023Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN. SURGEON'S ORIGINAL PLAN WAS TO CONVERT THE PATIENT'S HEMI HIP TO A TOTAL HIP BY REVISING THE UNIPOLAR COMPONENT. HOWEVER, WHEN HE TAPPED ON THE COMPONENT, THE STEM CAME OUT OF THE PATIENT'S FEMUR. ALL COMPONENTS WERE REVISED WITH STRYKER ACETABULAR COMPONENTS AND COMPETITOR FEMORAL COMPONENTS.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 17011849 ↗InjuryApr 28, 2023Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY AND PAIN. INTRA-OPERATIVELY, THE CEMENTED STEM WAS ALSO FOUND TO BE ASEPTICALLY LOOSE. A HEMI HIP CONSTRUCT WAS REMOVED AND A TOTAL HIP CONSTRUCT IMPLANTED.
Patient problems: Inadequate Osseointegration; Joint Laxity; Pain
MAUDE report 16831683 ↗MalfunctionApr 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A REVISION THA, WHEN A NURSE OPENED THE PACKAGE, OUR SALES STAFF NOTICED THERE WAS NO LOCKING RING WITH THE INSERT. THE LOCKING RING HAD CAME OFF FROM THE INSERT INSIDE THE PACKAGE. THERE WAS NO SPARE (SAME SIZE) SO A SURGEON TRIED TO PUT THE RING ON THE INSERT BUT IT DID NOT FIT DUE TO LOOSE. HE DIRECT A NURSE TO OPEN 2041C-2848 AND REMOVED A RING FROM INSERT OF 2041C-2848. HE PUT IT ON THE INSERT OF 2041C-2846 AND IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16812899 ↗InjuryMar 13, 2023Unstable; Unstable
PATIENT REPORTS SHE HAD A HIP REPLACEMENT INCLUDING A 32MM V40 HEAD IMPLANTED IN 2012 AND WOULD LIKE TO KNOW IF HER IMPLANTS WERE SUBJECT TO RECALL. UPDATE 15-FEB-2023: PATIENT REPORTED REVISION ON (B)(6) 2022 DUE TO INSTABILITY, "KNEE POPPING" AND DIFFICULTY WALKING.
Patient problems: Ambulation or Postural Difficulties; Joint Laxity
MAUDE report 16535036 ↗
Other Howmedica Osteonics Corp. products
- Triathlon608 models · 3,524 reports · 15 recalls
- Scorpio107 models · 113 reports · 28 recalls
- Trident160 models · 1,280 reports · 2 recalls
- Accolade57 models · 1,228 reports
- Duracon58 models · 65 reports · 16 recalls
- LFIT23 models · 852 reports
- TRIDENT II42 models · 188 reports · 12 recalls
- INSTRUMENT131 models · 290 reports · 7 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page