Optetrak 204-70-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862049872), received between Sep 8, 2023 and Sep 8, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

7 other recalls cover devices cleared under the same FDA submission (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A PATIENT, UNDERWENT AN INITIAL RIGHT TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2020 DUE TO OSTEOARTHRITIS. THE PATIENT UNDERWENT REVISION SURGERY OF HER RIGHT KNEE (B)(6) 2021, APPROXIMATELY 1 YEAR 9 MONTHS POST INITIAL PROCEDURE. COMPLICATIONS -THERE WAS A STEM TIBIAL COMPONENT IN PLACE. ON EXTRACTION OF THE TIBIAL COMPONENT THERE WAS FRACTURE OF THE PROXIMAL MEDIAL TIBIA. THIS DID NOT EXTEND DISTALLY. THERE IS NO VIOLATION OF THE MEDIAL RETINACULUM OR MEDIAL COLLATERAL LIGAMENT. THE TIBIAL EXTRACTOR WAS APPLIED AND ON BACKSLAPPING THE TIBIAL COMPONENT, THERE WAS NOTED TO BE REMOVAL OF THE TIBIAL TRAY HOWEVER THE MEDIAL PROXIMAL TIBIA REMAINED ATTACHED TO THE TRACHEA AND THERE WAS FRACTURE. THE PROXIMAL LATERAL TIBIA WITH THE TIBIAL TUBERCLE REMAINED INTACT. THERE IS NO EXTENSION OF THE FRACTURE DISTALLY. IT DID NOT REQUIRE ANY FRACTURE FIXATION BUT INSTEAD USE OF A PRESS-FIT TIBIAL SLEEVE WITH A LONG PRESS-FIT TIBIAL STEM WAS PLANNED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 17710179 ↗

Recalls under the same FDA submission

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

• 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-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-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-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-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-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-0347-05 · Nov 11, 2004 · Terminated
  Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.