Optetrak 200-65-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862041142), received between Nov 20, 2018 and Aug 4, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

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

5 other recalls cover devices cleared under the same FDA submission (K932690); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A MALE PATIENT WHO HAD A RIGHT KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE OF THEIR KNEE DEVICE SECONDARY TO POLYETHYLENE LINER WEAR RESULTING IN ASEPTIC LOOSENING AND SYNOVITIS OF THE RIGHT TOTAL KNEE ARTHROPLASTY. DESPITE UNDERGOING THE REVISION SURGERIES, PLAINTIFF EXPERIENCES DAILY KNEE PAIN AND DISCOMFORT WHICH LIMIT PLAINTIFF¿S ACTIVITIES OF DAILY LIVING AND RECREATION AND IMPACTS PLAINTIFF¿S QUALITY OF LIFE. AS A DIRECT, PROXIMATE AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE KNEE DEVICE AS DESCRIBED HEREIN, PLAINTIFF HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; METALLOSIS; SOFT TISSUE DAMAGE; INFECTION; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. NO FURTHER INFORMATION AVAILABLE. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Aseptic loosening; Discomfort; Pain; Synovitis; Unspecified Infection

  MAUDE report 22702211 ↗
• InjuryNov 20, 2018Naturally Worn; Peeled/Delaminated; Naturally Worn

  INDEX SURGERY: (B)(6) 2012. THE SURGEON OPENED THE JOINT IN STANDARD FASHION. THE SURGEON POPPED OUT THE LINER LIKE THE SURGEON USUALLY DOES, WITH A MAUDLIN HANDLE. THE SURGEON CHECKED OUT THE POLY AND NOTICED THAT IT WAS DELAMINATED IN THE DEEPEST PART OF THE ARTICULATING SURFACE. THE SURGEON THOUGHT THIS WAS DUE TO THE PATIENT BEING VERY HARD ON HIS KNEE. THE PATIENT IS A VERY HARDWORKING WHO DID NOT TAKE IT EASY ON IT'S TOTAL KNEE. THE SURGEON ALSO SAID THAT THE PATIENT¿S PCL HAD BEEN RUPTURED. THIS WAS ENABLING THE KNEE TO SHUCK BACK AND FORTH IN A WAY THAT IT WASN¿T SUPPOSED TO. THE SURGEON DECIDED TO TRIAL A CRC, WHICH FIT VERY WELL AND GOT RID OF THE SHUCK. THE SURGEON IMPLANTED THE FINAL POLY, A LOGIC CRC SIZE 5, 11 MM, AND CLOSED THE JOINT.

  Patient problems: Muscle/Tendon Damage; Rupture

  MAUDE report 8091141 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932690. One submission often covers many models, so check the product and lot details in each record.

• Z-2155-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
• Z-2156-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
• Z-2157-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
• Z-2158-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
• 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-