NA 213-64-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862059833), received between Mar 4, 2021 and Jun 26, 2022 — classified as 4 malfunctions.

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

5 other recalls cover devices cleared under the same FDA submission (K032606, K033883, K093360, K111400, K121307, K123687, K140302, K935773); 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2022Break; Break

  AS REPORTED, DURING IMPACTION BLACK PLASTIC COATING ON THE IMPACTION HANDLE CHIPPED LOOSE DURING IMPACTION OF THE TRIAL FEMUR. SURGEON NOTICED RIGHT AWAY AND HE CHECKED THE SURGICAL SITE FOR DEBRIS. CONFIRMED CLEAN AND PROCEDURE CARRIED ON WITH NO DELAY. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT IN STABLE CONDITION. SALES REP WAS UNABLE TO OBTAIN PHOTOS OR X-RAYS. PRODUCT WILL BE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14823467 ↗
• MalfunctionApr 7, 2022Break; Break

  AS REPORTED, PART OF THE IMPACTOR BROKE OFF DURING THE IMPACTION OF THE FEMORAL COMPONENT. THE IMPLANT WAS ALREADY SEATED AND CAUSED NO DELAY TO SURGERY. THERE WAS NO PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE. THE SURGICAL SITE WAS CONFIRMED CLEAN BY SURGEON AND THE PROCEDURE CARRIED ON WITH NO DELAY. PATIENT REMAINED IN STABLE CONDITION. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE WILL BE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14046308 ↗
• MalfunctionDec 22, 2021Fracture; Fracture

  AS REPORTED, DURING IMPACTION, THE HEAD OF THE FEMORAL IMPACTOR IS FRACTURED. THERE WERE NO PARTS OR PIECES OF THE DEVICE FELL INTO THE PATIENT WOUND SITE. THERE WAS NO SURGICAL DELAY/PROLONGATION. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13061424 ↗
• MalfunctionMar 4, 2021Break; Break

  AS REPORTED, WHEN IMPACTING THE FINAL FEMUR, THE PLASTIC ON THE LOCKING FEMORAL IMPACTOR BROKE. THIS INCIDENT CAUSED NO DELAY, THE PATIENT WAS NOT AFFECTED, AND THE SURGERY OUTCOME WAS GREAT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11417506 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032606, K033883, K093360, K111400, K121307, K123687, K140302, K935773. One submission often covers many models, so check the product and lot details in each record.

• Z-0583-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
• Z-0584-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
• Z-0021-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts,
• Z-0906-2015 · Oct 9, 2014 · Terminated
  Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants
• Z-2310-2012 · Aug 19, 2011 · Terminated
  OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three produ