BioloxRecalls & reported problems across all models
Howmedica Osteonics Corp. · 25 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Biolox model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 191
- Deaths reported
- 0
- Injuries reported
- 160
- Recalls
- 2
We found 25 models of Biolox by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 191 adverse event reports in the FDA's MAUDE database, received between Jan 17, 2017 and Jun 15, 2026 — classified as 160 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (34 reports).
2 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
Biolox 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.
- Jan 14, 2022Class IIOpen, Classified
Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling
Z-0843-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 14, 2022Class IIOpen, Classified
Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling
Z-0842-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Biolox problems
Device problems
- Insufficient Device Problem Information34
- Device Dislodged or Dislocated31
- Adverse Event Without Identified Device or Use Problem30
- Fracture28
- Unstable27
- Inaccurate Information12
- Degraded8
- Detachment of Device or Device Component6
Patient problems
- Injury52
- Insufficient Information31
- Ambulation or Postural Difficulties29
- Joint Dislocation28
- Pain20
- Unspecified Infection18
- No Clinical Signs, Symptoms or Conditions16
- Joint Laxity12
Biolox models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Biolox 6570-0-032Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 recall16 reports
- Biolox 6570-0-232Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 recall15 reports
- Biolox 6570-0-136Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented24 reports
- Biolox 6570-0-236Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented18 reports
- Biolox 6570-0-736Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented17 reports
- Biolox 6570-0-132Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented15 reports
- Biolox 6570-0-036Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented14 reports
- Biolox 6570-0-028Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented10 reports
- Biolox 6570-0-436Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented9 reports
- Biolox 6570-0-536Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented9 reports
- Biolox 6570-0-128Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented8 reports
- Biolox 6570-0-228Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented8 reports
- Biolox 6519-1-036Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented6 reports
- Biolox 6519-1-032Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- Biolox 6519-1-040Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- Biolox 6570-0-328Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- Biolox 6519-1-028Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Biolox 18-2800Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Biolox 18-3605Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Biolox 18-36-5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Biolox 18-32-3Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Biolox 18-2805Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Biolox 18-3205Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Biolox 18-3600Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Biolox 18-3625Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
Recent Biolox adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 15, 2026Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO CRACK/FRACTURE OF THE CERAMIC FEMORAL HEAD. PATIENT DENIES ANY TRAUMA. INTRA-OPERATIVELY, THE FOLLOWING WAS OBSERVED: THE CERAMIC FEMORAL HEAD WAS BROKEN INTO SEVERAL PIECES. AS A RESULT, THE TRUNNION OF THE STEM GOUGED INTO THE LINER. THE HEAD AND LINER WERE REVISED TO A METAL HEAD AND POLY LINER. REP CONFIRMED THAT SOME ADDITIONAL INFORMATION MAY BE ABLE TO BE PROVIDED. SURGEON WOULD LIKE THE INVESTIGATION RESULTS.
Patient problems: Insufficient Information
MAUDE report 25511244 ↗MalfunctionMay 28, 2026Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: "THE CERAMIC FEMORAL HEAD WAS IMPLANTED BY THE SURGICAL REG BY TAPPING WITH A REGULARLY USED HAMMER. WITH JUST ONE TAP, THE CERAMIC HEAD SHATTERED INTO MULTIPLE PIECES. BIOLOX DELTA HEAD APPLIED BY SURGICAL SPR USING CORRECT HAMMER AND IMPACTOR. SINGLE STRIKE AND HEAD SHATTERED. SWAB UNDER TRUNNION AND TRUNNION HAD BEEN CLEANED AFTER FINAL TRIAL- NO OBVIOUS TRUNNION DEFORMITY NOTED AT THAT STAGE SWAB APPEARED TO HAVE CAUGHT ALL THE FRAGMENTS. TRUNNION OF FEMORAL STEM SCORED". REMEDIAL ACTIONS TAKEN BY HEALTHCARE FACILITY: "INFORMED THE CONSULTANT, WHO THEN REMOVED THE SHATTERED PIECES AND THE STEM. A WASHOUT AND REPLACED WITH A NEW STEM AND CERAMIC HEAD".
Patient problems: Insufficient Information
MAUDE report 25315131 ↗InjuryMay 27, 2026Noise, Audible
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SQUEAKING. THE HIP CONSTRUCT HAD A POLY LINER WITH A CERAMIC HEAD, BUT THE SURGEON SUSPECTS THAT THERE IS A POSSIBLE UNSPECIFIED ISSUE INSIDE THE HEAD. THE HEAD AND LINER WERE REVISED TO A NEW POLY LINER WITH METAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Insufficient Information
MAUDE report 25304283 ↗InjuryMay 6, 2026Degraded; Use of Device Problem
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO ECCENTRIC POLY WEAR. INTRA-OPERATIVELY, IT WAS REPORTED THAT THE PATIENT HAD A 32MM CERAMIC FEMORAL HEAD INSIDE OF A 36D LINER, DESPITE THE USAGE FROM THE PRIOR PROCEDURE DOCUMENTING THAT A 36MM FEMORAL HEAD WAS IMPLANTED IN THE 36D LINER. THE HEAD AND LINER WERE REVISED TO A 36MM FEMORAL HEAD WITH A 36D LINER. HOSPITAL STAFF WANTS TO SPEAK TO SOMEONE AT STRYKER REGARDING THE FACT THAT A 32MM FEMORAL WAS IMPLANTED IN A 36D LINER AND SURGEON WANTS INVESTIGATION RESULTS. REP WILL PROVIDE ALL AVAILABLE DOCUMENTATION AND IMAGES AVAILABLE FROM THE HOSPITAL AND SURGEON.
Patient problems: Insufficient Information
MAUDE report 25104146 ↗InjuryMay 4, 2026Degraded; Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: ON (B)(6) 2026, A SALES REPRESENTATIVE RECEIVED AN EMAIL FROM REPORTING THAT A PATIENT HAD PRESENTED FOR MEDICAL CONSULTATION COMPLAINING OF PAIN IN THE RIGHT HIP, WHICH HAD UNDERGONE A RIGHT TOTAL HIP ARTHROPLASTY (THA) WITH A TRIDENT-ACCOLADE PROSTHESIS AT ANOTHER CLINIC IN 2019. X-RAYS SHOWED A LOSS OF SYMMETRY AND MISALIGNMENT OF THE HIP HEAD RELATIVE TO THE NECK. A COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED THAT THE STEM WAS BROKEN AT THE NECK. ON (B)(6) 2026, SURGICAL REVISION WAS PERFORMED, REVEALING A LOOSE CERAMIC HEAD, A STEM WITH AN AXIALLY BROKEN NECK, AND A MISSING FRAGMENT, ALL ASSOCIATED WITH SIGNIFICANT METALLOSIS AND SEVERE OSTEOLYSIS OF THE PROXIMAL FEMUR WHERE THE STEM WAS LOCATED. THE SURGEON WAS ABLE TO CLEAN THE AREA, REMOVE ALL DEBRIS, AND RECONSTRUCT THE HIP WITH A RECONSTRUCTION STEM AND REPLACE THE LINING. IN THE ATTACHMENT-INTAKE ARE PICTURES OF THE SURGERY REVISION.
Patient problems: Insufficient Information; Metal Related Pathology; Osteolysis; Pain
MAUDE report 25072462 ↗InjuryApr 24, 2026Device Dislodged or Dislocated
THE FOLLOWING INFORMATION WAS PROVIDED: LEFT HIP REVISION. PT PRESENTED WITH A DISLOCATED HIP FOLLOWING A "COMPLEX" THA. DR. OPTED TO REVISE THE COMPETITOR LINER OPTION AND SWAP OUT OUR '32MM-4 HEAD' TO A '32MM+0 UNIVERSAL' OPTION. NO COMPLAINTS HAVE BEEN FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 24979779 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: REFERRED BY A GENERAL PRACTITIONER DUE TO ACUTE PAIN IN THE LEFT HIP AND A HISTORY OF LEFT HIP REPLACEMENT 6 YEARS AGO. MILD PAIN IN THE LEFT HIP SINCE THE PREVIOUS DAY; SUBSEQUENTLY, SEVERE PAIN AND A ¿CRACKING¿ SENSATION IN THE LEFT HIP, TO THE POINT THAT SHE COULD NO LONGER BEAR WEIGHT ON HER LEFT LOWER EXTREMITY. UPON QUESTIONING, THE PATIENT REPORTED HAVING HAD RECURRING PAIN AND ALSO SCIATIC SYMPTOMS.
Patient problems: Insufficient Information
MAUDE report 24953792 ↗InjuryApr 2, 2026Device Dislodged or Dislocated
THE FOLLOWING INFORMATION WAS PROVIDED: REVISED A STRYKER HIP (RIGHT). THIS COMPONENT IS BEING REVISED DUE TO 3 DISLOCATIONS. NO VISIBLE SIGNS OF DAMAGE NOR WEAR TO THE HEAD, POLY AND TRUNNION. HE REPLACED THE HEAD WITH A 6260-9-236 (LFIT 36 +5). THE LINER WAS NOT REMOVED AND STAYED WITHIN THE PATIENT. THE SURGEON DID NOT WANT TO REMOVE.
Patient problems: Joint Dislocation
MAUDE report 24765551 ↗InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: INFECTION. SWAPPED OUT OTHER COMPANY¿S LINER AND OUR FEMORAL HEAD IMPLANT.
Patient problems: Unspecified Infection
MAUDE report 23839376 ↗InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION DUE TO AN INFECTION DR. REMOVED THE FOLLOWING ITEM: 6570-0-536, LOT: 29826453. THERE IS NO NOTICEABLE DAMAGE OR WEAR. HOSPITAL WILL NOT RELEASE PT INFO NOR THE EXPLANT.
Patient problems: Unspecified Infection
MAUDE report 23743737 ↗InjuryDec 8, 2025Adverse 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 POSSIBLE INFECTION. THE HEAD, SLEEVE AND COMPETITOR LINER WERE REVISED TO ANOTHER CERAMIC HEAD, SLEEVE AND COMPETITOR LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Unspecified Infection
MAUDE report 23743029 ↗InjuryNov 26, 2025Fracture; Fracture
InjuryNov 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 20, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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