Optetrak 208-21-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862054081), received between Oct 30, 2020 and Jul 2, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K954208); 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 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0019-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2024Unstable; Unstable

  AS REPORTED, APPROXIMATELY 12 YEARS 8 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT, THE PATIENT WAS REVISED DUE TO INSTABILITY OVERTIME. THE PATIENT WAS REVISED TO CC TIBIAL INSERT SZ 1 18MM. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT NOT RETURNING DUE TO HOSPITAL POLICY.

  Patient problems: Joint Laxity

  MAUDE report 19659309 ↗
• InjuryOct 11, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT THIS 75 Y/O FEMALE PATIENT HAD A PARTIAL REVISION 6 YEARS POST OP INITIAL TKA. THE PATIENT WAS SUFFERING, WAS PRESENTING LAXITY & INSTABILITY. SYNOVECTOMY & LAVAGE WERE PERFORMED. THE PE RETRIEVED APPEARED TO BE BADLY DAMAGED FOR BOTH TIBIAL INSERT & PATELLA. SURGEON REPLACED BOTH INSERT & PATELLA, SWITCHING FROM 9MM TO 11MM. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 17912967 ↗
• InjuryOct 30, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2011, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2004. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10760057 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954208. One submission often covers many models, so check the product and lot details in each record.

• Z-0582-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-