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Optetrak 204-22-09Recalls & reported problems

Exactech, Inc. · Class 2 · Implant

All models of Optetrak (336)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
21
Deaths reported
0
Injuries reported
21
Recalls naming it
1

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10885862048226), received between Oct 7, 2020 and Jun 24, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Naturally Worn” (12 reports).

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

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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 2 reportsJun 2024: 3 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Aug 30, 2021Class IIOpen, 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

Device problems

  • Naturally Worn12
  • Unstable8
  • Insufficient Device Problem Information6
  • Adverse Event Without Identified Device or Use Problem3
  • Degraded1
  • Lack of Effect1
  • Loosening of Implant Not Related to Bone-Ingrowth1
  • Mechanical Problem1

Patient problems

  • Failure of Implant13
  • Joint Laxity6
  • Pain6
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
  • Insufficient Information5
  • Osteolysis5
  • Swelling/ Edema3
  • Ambulation or Postural Difficulties2

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 24, 2026Unstable

    AS REPORTED, APPROXIMATELY 14 YEARS AND 4 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT EXPERIENCED AN UNSTABLE KNEE, COMPLAINED OF PAIN, AND WAS REVISED TO A NEW POLY. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Patient problems: Joint Laxity; Pain

    MAUDE report 25612997 ↗
  • InjuryJun 18, 2025Naturally Worn; Naturally Worn

    AS REPORTED, APPROXIMATELY EIGHTEEN YEARS POST INITIAL RIGHT TSA, A PATIENT WAS REVISED DUE TO POLY FLAKING AND DELAMINATION, PATELLA MAL TRACKING THAT REQUIRED A NEW PATELLA AND TRIMMING/CLEAN UP OF THE EFFECTED BONE. PATIENT WAS REVISED TO EXACTECH DEVICES AND PATELLA AND LINER WERE EXCHANGED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Patient problems: Insufficient Information

    MAUDE report 22285148 ↗
  • InjuryJan 13, 2025Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 117 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND LOOSENING OF THE TIBIAL COMPONENT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POSTOPERATIVE DIAGNOSIS NOTED LOOSE LEFT KNEE TIBIAL COMPONENT. INTRAOPERATIVELY TWO WOUND CULTURES WERE SENT OFF WITH NO INFECTION APPRECIATED AND CULTURE RESULTS WERE UNREMARKABLE. IT WAS NOTED THAT THE SURGEON ELECTED DO THE TIBIAL REVISION AND NOT THE WHOLE KNEE. IT WAS NOTED THAT THE TIBIAL COMPONENT WAS SIGNIFICANTLY LOOSE. PATIENT WAS REVISED TO EXACTECH DEVICES. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0019-2022 204-22-09 - PS TIBIAL INSERTS SZ 2, 9MM SERIAL: (B)(6)510K: K933610 UDI: (B)(4)' PRODUCT CODE: JWH X-RAY: NO OPERATIVE NOTES: YES.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

    MAUDE report 21137666 ↗
  • InjuryJun 24, 2024Naturally Worn; Naturally Worn

    AS REPORTED, APPROXIMATELY 12 YEARS AND 6 MONTHS POST THE INITIAL RIGHT TKA, THE PATIENT WAS REVISED DUE TO POLY ISSUES WITH FLAKING AND DELAMINATION. A SMALL PORTION OF THE MEDIAL TIBIA HAD SIGNS OF OSTEOLYSIS. THE POLY AND PATELLA WERE EXCHANGED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Patient problems: Osteolysis

    MAUDE report 19594438 ↗
  • InjuryJun 4, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 202 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SYNOVITIS, AND SEVERE WEAR OF THE PATELLA UNDERMINING OSTEOLYSIS. THERE WAS ALSO NOTED WEAR OF THE POST AND BONE LOSS AFTER REMOVAL OF THE FEMORAL COMPONENT. THE PATIENT WAS PRESENTED WITH PAIN, RECURRENT EFFUSIONS AND OSTEOLYSIS WITH INSTABILITY OF THE LEFT KNEE DUE TO POLY WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Joint Laxity; Joint effusion; Osteolysis; Pain; Synovitis

    MAUDE report 19458392 ↗
  • InjuryJun 4, 2024Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT APPROXIMATELY 190 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR WITH DELAMINATION AND DEFORMATION OF THE POST, FLECKS OF POLYETHYLENE VISIBLE IN SOFT TISSUES, SEVERE OSTEOLYSIS LATERAL FEMORAL CONDYLE AND LATERAL FEMORAL BONE LOSS, LATERAL TIBIAL BONE LOSS, SEVERE POLY WEAR OF THE PATELLAR COMPONENT, AND DEBONDED FEMORAL COMPONENT EASILY REMOVED WITH A BONE TAMP. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Joint Laxity; Osteolysis

    MAUDE report 19457774 ↗
  • InjuryMay 13, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 189 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE REVISION SURGERY FOR PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Failure of Implant; Insufficient Information

    MAUDE report 19302785 ↗
  • InjuryMay 8, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2009, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 14 YEARS, 4 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Pain

    MAUDE report 19268977 ↗
  • InjuryDec 20, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2008. APPROXIMATELY 6 YEARS AND 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2015. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN (B)(6) WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT O

    Patient problems: Insufficient Information

    MAUDE report 18366589 ↗
  • InjuryOct 3, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REVISION IN 2014. EVEN WITH THE REVISION, THE PATIENT STILL EXPERIENCED PAIN, SWELLING, AND LOSS OF FUNCTIONALITY WITH HER RIGHT KNEE. MULTIPLE TESTS AND BIOPSIES AGAIN DID NOT REVEAL THE SPECIFIC PROBLEM. ON (B)(6) 2022, THE SURGEON PERFORMED AN ARTHROSCOPIC PROCEDURE TO DETERMINE WHAT WAS HAPPENING IN THE PATIENT¿S KNEE. THE PROCEDURE REVEALED A COLLECTION OF POLYETHYLENE RESIDUE FROM THE ARTIFICIAL CARTILAGE BETWEEN THE METAL HALVES OF THE EXACTECH KNEE REPLACEMENT DEVICE JOINT HALVES. THE SURGEON CLEANED AND FLUSHED THE AREA, BUT RECOMMENDED THAT SOON, ANOTHER KNEE REVISION/REPLACEMENT SURGERY WAS GOING TO HAVE TO BE DONE TO ALLEVIATE THE PROBLEM. ON (B)(6) 2022, THAT THE COMPLAINANT AND HER PHYSICIAN DISCOVERED THAT THE PROBLEM AROSE FROM THE DEFECTIVE EXACTECH KNEE REPLACEMENT DEVICE. FINALLY, ON (B)(6) 2022, THE PATIENT UNDERWENT A THIRD KNEE REPLACEMENT SURGERY (HER SECOND REVISION SURGERY) TO REPLACE THE EXACTECH KNEE REPLACEMENT DEVICE. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE

    Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Pain; Swelling/ Edema

    MAUDE report 17860009 ↗
  • InjuryJul 11, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

    AS REPORTED, APPROXIMATELY 14 YEARS POST OP INITIAL RIGHT TKA, THIS 83 Y/O FEMALE PATIENT WAS REVISED. KNEE WAS UNSTABLE, SURGEON DID A POLY EXCHANGE OF OLD OPTETRAK. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNKNOWN MEDICAL HISTORY. X-RAY WAS PROVIDED AS WELL AS A PICTURE OF HER OPERATIVE REPORT FROM 2009. PRODUCT NOT BEING RETURNED DUE TO THE ACCOUNT WOULD NOT RETURN THE PRODUCT DUE TO THEIR GUIDELINES.

    Patient problems: Failure of Implant; Joint Laxity

    MAUDE report 17297215 ↗
  • InjuryJun 2, 2023Mechanical Problem; Unstable; Naturally Worn; Insufficient Device Problem Information; Mechanical Problem; Unstable; Naturally Worn; Insufficient Device Problem Information

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6) 2006. THEIR LEFT KNEE REVISION WAS (B)(6) 2022, APPROXIMATELY 16 YEARS 1 MONTH AFTER THEIR INITIAL PROCEDURE DUE TO PAIN AND DISCOMFORT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Implant Pain; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

    MAUDE report 17054579 ↗
  • InjuryMay 24, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Lack of Effect; Unstable; Naturally Worn; Insufficient Device Problem Information; Lack of Effect

    ADDITIONAL INFORMATION VIA LEGAL DEPARTMENT-THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. (B)(4), AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE. REVISION OPERATIVE REPORT OF (B)(6) 2015 -INSTABILITY OF LEFT TOTAL KNEE ARTHROPLASTY. PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. ¿INSPECTION OF THE KNEE SHOWED AN EXTENSIVE AMOUNT OF PROLIFIC SYNOVIUM WITH POLYETHYLENE DEBRIS. THERE WAS 1-2 MM OF LAXITY IN EXTENSION. IN MID FLEXION, THERE WAS APPROXIMATELY 1 CM OF LATERAL-SIDED LAXITY AND AT 90 DEGREES OF FLEXION, THERE WAS LAXITY LATERALLY, AS WELL AS APPROXIMATELY 1 CM OF ANTERIOR TRANS

    Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Insufficient Information; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

    MAUDE report 16992181 ↗
  • InjuryJul 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED BY LEGAL THAT THIS FEMALE PATIENT'S RIGHT KNEE WILL BE SCHEDULED FOR A REVISION DUE TO A "DEFECTIVE" PRODUCT. REASON FOR THE REVISION IS UNKNOWN.

    Patient problems: Failure of Implant

    MAUDE report 14944692 ↗
  • InjuryJul 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED BY THE LEGAL TEAM THAT THIS FEMALE PATIENT'S LEFT KNEE WAS REVISED. REASON FOR REVISION WAS NOT REPORTED.

    Patient problems: Failure of Implant

    MAUDE report 14944148 ↗
  • InjuryDec 30, 2021Naturally Worn; Naturally Worn

    AS REPORTED, APPROXIMATELY SIX MONTHS POST RIGHT TKA IMPLANTATION, A (B)(6) FEMALE PATIENT HAD ANTERIOR KNEE PAIN AND A POLY AND PATELLA EXCHANGE WAS MADE. THERE WERE NO PARTS OR PIECES FELL INTO THE PATIENT WOUND AREA. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURN.

    Patient problems: Failure of Implant

    MAUDE report 13122488 ↗
  • InjuryDec 4, 2020Degraded; Degraded

    IT WAS REPORTED THAT A (B)(6) PATIENT AT 94 KG EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2016, DUE TO PROSTHESIS WEAR. INITIAL SURGERY DATE WAS (B)(6) 2007. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

    Patient problems: Failure of Implant

    MAUDE report 10946532 ↗
  • InjuryOct 30, 2020Unstable; Unstable

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2011, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2008. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

    Patient problems: Failure of Implant

    MAUDE report 10760071 ↗
  • InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2008, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2007. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

    Patient problems: Unspecified Infection

    MAUDE report 10661597 ↗
  • InjuryOct 7, 2020Unstable; Unstable

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2005, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2004. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

    Patient problems: Failure of Implant

    MAUDE report 10641575 ↗
  • InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2005, DUE TO RANGE OF MOTION/STIFFNESS. INITIAL SURGERY DATE WAS (B)(6) 2005. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

    Patient problems: Failure of Implant

    MAUDE report 10641032 ↗

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-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-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-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.

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