Biolox 6570-0-232Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04546540608536), received between May 25, 2018 and Dec 18, 2025 — classified as 8 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Inaccurate Information” (6 reports).

1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 14, 2022Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMar 29, 2022Inaccurate Information; Inaccurate Information

  PRIMARY PROCEDURE, LEFT HIP. IT WAS REPORTED THAT AN IMPLANT'S PACKAGING AND LABELS INDICATED A 32 +4 CERAMIC HEAD, BUT THE DEVICE WAS MARKED AS A 32 -4 CERAMIC HEAD. A SECOND DEVICE OF THE SAME LOT WAS OPENED AND THE SAME ISSUE OCCURRED. A 32 +4 HEAD OF A DIFFERENT LOT WAS OPENED AND IMPLANTED. PROCEDURE COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 2 MINUTES. REP CONFIRMED THE IMPLANTS WERE HOSPITAL OWNED. REP CONFIRMED THAT HE CAN PROVIDE PICTURES, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939620 ↗
• MalfunctionMar 29, 2022Inaccurate Information; Inaccurate Information

  PRIMARY PROCEDURE, LEFT HIP. IT WAS REPORTED THAT AN IMPLANT'S PACKAGING AND LABELS INDICATED A 32 +4 CERAMIC HEAD, BUT THE DEVICE WAS MARKED AS A 32 -4 CERAMIC HEAD. A SECOND DEVICE OF THE SAME LOT WAS OPENED AND THE SAME ISSUE OCCURRED. A 32 +4 HEAD OF A DIFFERENT LOT WAS OPENED AND IMPLANTED. PROCEDURE COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 2 MINUTES. REP CONFIRMED THE IMPLANTS WERE HOSPITAL OWNED. REP CONFIRMED THAT HE CAN PROVIDE PICTURES, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939618 ↗
• MalfunctionFeb 8, 2022Inaccurate Information; Inaccurate Information

  DISTRIBUTOR REPORTED THAT OUTER PACKAGING MARKING INDICATED 32/+4 (6570-0-232) AS DID THE INNER PACKAGING, HOWEVER A 32/-4 (6570-0-032) WAS PACKAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13481261 ↗
• MalfunctionJan 19, 2022Inaccurate Information; Inaccurate Information

  PRIMARY PROCEDURE, LEFT HIP. IT WAS REPORTED THAT A FEMORAL HEAD WAS LABELLED AS A 32 +4 BIOLOX HEAD, BUT INSIDE THE PACKAGING WAS A 32 -4 BIOLOX HEAD. DISCOVERY WAS MADE WHEN THE HEAD WAS IMPACTED ON THE STEM AND THE SURGEON NOTED THE HEAD WAS SITTING LOWER THAN EXPECTED. AS THERE WERE NO OTHER BIOLOX HEADS AT THE HOSPITAL A 32 +4 LFIT HEAD WAS IMPLANTED INSTEAD. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 2-3 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289963 ↗
• MalfunctionJan 19, 2022Inaccurate Information; Inaccurate Information

  A 32-4 HEAD WAS IMPLANTED AND REMOVED. THE BOX WE OPENED INDICATED THAT THE HEAD WAS A 32+4. THE PA NOTICED THE SCRIPT ON THE 32-4 HEAD & IT WAS REPLACED WITH A 32 UNIVERSAL AND A +4 SLEEVE. THIS WAS A PRIMARY. THE DELAY WAS NO MORE THAN 5 MINUTES. RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289961 ↗
• MalfunctionJan 11, 2022Inaccurate Information; Inaccurate Information

  THE END USER OBSERVED AN IMPLANT MISMATCH. THE IMPLANT INDICATED ON THE PACKAGING DID NOT CORRESPOND TO THE FINAL CONTENTS, THE OUTER PACKAGING THAT INDICATED A CERAMIC HEAD +4MM, BUT AFTER CHECKING IT AND BEING TAKEN OUT OF THE PACKAGING, IT TURNED OUT TO BE CERAMIC HEAD -4MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13222236 ↗
• InjuryOct 4, 2021Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  THE SURGEON IS ASKING HAS THERE BEEN ANY PRODUCT WARNINGS ON THE IMPLANTS AS HE SEES EVIDENCE OF METALLOSIS. UPDATE: THERE ARE SIGNS OF WEAR ON THE TRUNNION OF THE ACCOLADE TZMF STEM EVEN THOUGH IT WAS A COC ARTICULATION. NOTICED WHEN PATIENT REPORTED PAIN AND ON SCANS. REVISION COMPLETED ON (B)(6) 2021.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 12568501 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  SUSPECTED INFECTION. PAIN. OSTEOLYSIS IN THE PROXIMAL PART OF THE FEMUR AND A TUMOR-LIKE SUBSTANCE CAN BE CONFIRMED ON CT. WEAR OF HEAD AND TMZF CANNOT BE DENIED. REVISION WILL BE DONE ON JUNE 9.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 12104247 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION. DELTA CERAMIC HEAD WAS REVISED TO NEW ONE. SLEEVE OR METAL HEAD SHOULD BE USED. SURGEON DECIDED TO JUST FOLLOW-UP IF THERE ARE NO COMPLICATIONS IN THE NEAR FUTURE.

  Patient problems: Unspecified Infection

  MAUDE report 11946392 ↗
• InjuryMar 16, 2021Device Difficult to Setup or Prepare; Use of Device Problem; Device Difficult to Setup or Prepare; Use of Device Problem

  THAT AFTER PERFORMING THE FINAL TRIAL WITH A 28 MM 4 MM HEAD AND DECIDING THE IMPLANT, SR ACCIDENTALLY OPENED THE 32 MM 4 MM IMPLANT. AFTER THE PROCEDURE, X-RAY REVEALED THAT THE INNER DIAMETER OF THE CUP AND THE DIAMETER OF THE HEAD DID NOT MATCH. SO 32 MM 4 MM WAS REVISED TO 28 MM 4 MM. UPDATE: THE PRIMARY IMPLANTATION TOOK PLACE THE SAME DAY AS THE REVISION. THE PATIENT WAS NOT TAKEN OFF OF ANESTHESIA AND THEN PUT BACK UNDER ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 11495908 ↗
• InjuryMay 8, 2020Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  PROCEDURE: THE PATIENT UNDERWENT RIGHT HIP CONVERSION (B)(6) 2014. PATIENT HAD A TRAUMATIC FALL AND DISLOCATED HIP AND SUBSEQUENTLY DEVELOPED RECURRENT INSTABILITY. PATIENT UNDERWENT RIGHT HIP REVISION, THE HEAD WAS EXCHANGED AND A CONSTRAINED LINER WAS USED. (B)(6) 2019.

  Patient problems: Injury

  MAUDE report 10039620 ↗
• MalfunctionSep 20, 2018Compatibility Problem; Compatibility Problem

  PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT THE FEMORAL HEAD WOULD NOT PROPERLY SEAT ON THE TRUNNION OF THE ACCOLADE II STEM. ANOTHER FEMORAL HEAD OF THE SAME CATALOG NUMBER (DIFFERENT LOT) WAS USED AND SEATED ON THE TRUNNION PROPERLY. A SURGICAL DELAY OF APPROXIMATELY 2 MINUTES WAS CAUSED. REP HAS THE IMPLANT BUT COULD NOT RETRIEVE ANY OF THE PACKAGING AS IT HAD BEEN DISPOSED BY HOSPITAL STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7895146 ↗
• InjuryJul 3, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  A 36E LINER WAS IMPLANTED WITH A 32+4 HEAD. THE PATIENT WAS REVISED THE SAME DAY.

  Patient problems: Injury

  MAUDE report 7658955 ↗
• InjuryMay 25, 2018Noise, Audible; Noise, Audible

  REVISION LEFT TOTAL HIP REPLACEMENT. PATIENT EXPERIENCED SQUEAKING & PAIN IN HIP JOINT WHEN UNDER LOAD. REMOVED STRYKER CERAMIC ACETABULAR INSERT & BIOLOX DELTA V40 FEMORAL HEAD. REPLACED WITH TRIDENT X3 POLYETHYLENE INSERT & BIOLOX DELTA V40 CERAMIC HEAD.

  Patient problems: Injury; Pain

  MAUDE report 7546049 ↗