Optetrak 208-24-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862054364), received between Oct 4, 2022 and Jun 1, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 16, 2026.

Recalls naming this device

1. Aug 30, 2021Open, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2024Naturally Worn; Naturally Worn

  IT WAS STATED THAT THE PATIENT HAS EXPERIENCED DAILY PAIN AND DISCOMFORT IN HIS RIGHT KNEE, WHICH HAS LIMITED HIS ACTIVITIES OF DAILY LIVING AND IMPACTED HIS QUALIFY OF LIFE. PATIENT HAS SUFFERED DEBILITATING INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND DISCOMFORT; SWELLING; GAIT IMPAIRMENT; POOR BALANCE; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; BONE DAMAGE; AND OTHER INJURIES PRESENTLY UNDIAGNOSED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19442368 ↗
• InjuryJun 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2016, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 7 YEARS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Failure of Implant; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19442202 ↗
• InjuryMar 19, 2024Material Discolored; Naturally Worn; Material Discolored; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6)2023, APPROXIMATELY 10 YEARS, 6 MONTHS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Cyst(s); Discomfort; Failure of Implant; Osteolysis; Pain; Scar Tissue

  MAUDE report 18932672 ↗
• InjuryOct 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL THAT A MALE PATIENT HAD RIGHT KNEE REPLACEMENT INDEX SURGERY ON (B)(6) 2011 AND A REVISION SURGERY ON (B)(6) 2019 APPROXIMATELY 8 YEARS AFTER IMPLANT. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15535790 ↗

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-