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BIOLOX® OPTION Head System 650-1061Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868248627), received between Oct 7, 2019 and Oct 7, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K082996); 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.

Most reported problems

Device problems

  • Break1
  • Fracture1

Patient problems

  • Bone Fracture(s)1
  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 7, 2019Break; Fracture; Break; Fracture

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND SUBSEQUENTLY UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE. THE HOSPITAL DID NOT REPORT ANY FALLS OR TRAUMA PRIOR TO THE REVISION SURGERY. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019 AND ON THE SAME DAY PRODUCTS WITH ITEM NUMBERS: 650-1061 AND 650-1057 WERE IMPLANTED.

    Patient problems: Bone Fracture(s); Pain

    MAUDE report 9161367 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082996. One submission often covers many models, so check the product and lot details in each record.

  • Z-3133-2024 · Aug 8, 2024 · Open, Classified
    Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1
  • Z-3132-2024 · Aug 8, 2024 · Open, Classified
    Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 6
  • Z-0301-2018 · Jun 5, 2017 · Terminated
    CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
  • Z-0302-2018 · Jun 5, 2017 · Terminated
    CER BIOLOXD OPTION HD 32MM, model # 650-1056

Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices

All Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices →

Sources and updates

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