NA 213-65-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862059895), received between Jun 19, 2020 and Nov 20, 2020 — classified as 2 malfunctions.

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

11 other recalls cover devices cleared under the same FDA submission (K011976, K093360, K101981, K932776, K933610); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2020Break; Break

  DURING SURGERY, THE SURGEON HIT ON THE LPI HANDLE TO IMPACT AND THE HANDLE BROKE IN TWO PIECES, ONE PART IN THE HAND & ANOTHER PART ON THE FLOOR. THERE WERE NO PIECES THAT WENT INSIDE THE BODY. NO CONSEQUENCE FOR THE PATIENT. THE DEVICE WILL BE RETURNED.

  Patient problems: No Patient Involvement

  MAUDE report 10874638 ↗
• MalfunctionJun 19, 2020Break; Break

  AS REPORTED, WHEN THE SURGEON INSERTED LOGIC FEMORAL TRIAL TO THE FEMUR USING THE LPI FEMORAL IMPACTOR ASSEMBLED THIS LPI IMPACTOR HAND AND A MALLET, THE IMPACTOR HANDLE HAD BEEN FRACTURED INTO TWO PIECES AT THE PART WHERE THE BLUE COLORED PLASTIC PART WAS NOT SUPPORTED BY ANY METALLIC PARTS. THEN WHEN THE FINAL FEMORAL COMPONENT (IMPLANT) WAS INSERTED, THE SURGEON IMPACTED THE REST OF THE BLUE COLORED PLASTIC PART FIXED TO THE METALLIC PART BY A MALLET HAD THE PART BEEN COMPLETELY BROKEN INTO 3 PIECES. THE OPERATION TIME WAS EXTENDED BY APPROX. 10 MIN DUE TO THIS INCIDENT, BUT THE FEMORAL COMPONENT WAS SEATED TO THE FEMUR WITHOUT ANY PROBLEM. DEVICE IS TO BE RETURNED. UPDATE 03-JUNE-2020: WE ANSWER THE TWO QUESTIONS: ARE WE READING THE EXPERIENCE REPORT CORRECTLY. THE SURGEON USED THE LPI INSTRUMENT AND BROKE IT IN HALF, INTO TWO SEPARATE PIECES. THEN THE SURGEON CONTINUED TO USE THE INSTRUMENT WHILE BROKEN WHICH IT THEN BROKE IT INTO 3 ADDITIONAL PIECES? YES, THAT¿S RIGHT. DID ANY PIECES FALL INTO THE WOUND SITE? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10174196 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011976, K093360, K101981, K932776, K933610. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-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-
• 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-2070-2012 · Sep 23, 2011 · Terminated
  Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 2
• 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
• Z-0927-06 · Dec 19, 2005 · Terminated
  Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONL
• Z-1379-05 · Jun 2, 2005 · Terminated
  The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SING
• Z-0347-05 · Nov 11, 2004 · Terminated
  Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.