Optetrak 204-23-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10885862048301), received between Oct 5, 2020 and Apr 20, 2026 — classified as 37 injuries.

The most frequently reported specific device problem is “Naturally Worn” (21 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.

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

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT A RIGHT KNEE REPLACEMENT. THE PATIENT LATER REQUIRED REVISION SURGERY DUE TO POLYETHYLENE WEAR. THE TIBIAL AND PATELLAR POLYETHYLENE COMPONENTS WERE REVISED, WITH THE PATELLAR COMPONENT DEMONSTRATING MORE SIGNIFICANT WEAR. THIS WAS ASSOCIATED WITH OSTEOLYSIS OF THE BONE, WHICH NECESSITATED BONE GRAFTING. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 24931358 ↗
• InjuryJul 29, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN. AS A RESULT, APPROXIMATELY FIFTEEN YEARS POST-SURGERY, THE PATIENT UNDERWENT A REVISION TO REPLACE THE POLYETHYLENE LINER DUE TO PROSTHESIS WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 22644801 ↗
• InjuryApr 28, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 15 YEARS POST INITIAL REPLACEMENT. THE REVISION WAS DUE TO POLY WEAR THAT DEVELOPED OVER TIME. PATIENT WAS REVISED TO SAME SIZE COMPONENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21923141 ↗
• InjuryApr 2, 2025Unstable; Unstable

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY AND SORENESS. SURGEON REVISED TIBIAL INSERT FROM 3/9MM TO 3/11MM. THERE WAS LITTLE TO NO OSTEOLYSIS.

  Patient problems: Ambulation or Postural Difficulties; Osteolysis; Pain

  MAUDE report 21755871 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 26 YEARS POST INITIAL OPERATION. PATIENT WENT TO SURGEON WITH A SORE KNEE WITH A LITTLE OSTEOLYSIS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 21698770 ↗
• InjuryAug 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 173 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, AND SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 20041527 ↗
• InjuryAug 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 79 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEARPAIN, DISCOMFORT, DIFFICULTY WALKING AS A RESULF OF THE DEFECTIVE NATURE OF THE EXACTECH KNEE REPLACEMENT SYSTEM. PLAINTIFF HAS SUFFERED AND MAY CONTINUE TO SUFFER SEVER AND PERMANENT PERSONAL INJURIES INCLUDING POLYETHYLENE WEAR AND DEVICE FAILURE, DISBURSEMENT OF THE POLYETYLENE LINER INTO BONE AND OTHER BODILY STRUCUTES. PAINFUL KNEE REVISION SURGERIES TO REMOVE OR REVISE THE DEFECTIVE DEVICE, CONTINUED REHABILITATION, MEDICAL CARE AND POSSIBLE ADDITIONAL SURGERIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Pain

  MAUDE report 19980153 ↗
• InjuryJun 27, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK DEVICE ON THE RIGHT KNEE AND THEN APPROXIMATELY 10 YEARS, 2 MONTHS LATER THE PATIENT WAS REVISED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN, SUFFERING, TROUBLE WALKING/STANDING, NEED FOR ADDITIONAL SURGERY AND THERAPIES AND ANY OTHER HARM AND LOSS AVAILABLE UNDER THE LAW. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. EBI INITIAL SURGERY. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. NO FURTHER INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 19624842 ↗
• InjuryJun 26, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  APPROXIMATELY 14 YEARS AFTER A RIGHT TOTAL KNEE REPLACEMENT, THE PATIENT RETURNED WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED POLY IMPLANT. UPON EXAMINATION, THE PATIENT UNDERWENT A POLY TIBIAL INSERT SWAP AND PATELLA SWAP. THE EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT .

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 19621172 ↗
• InjuryMay 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A TOTAL LEFT KNEE ARTHROPLASTY (B)(6) 2009 AND WAS SURGICALLY REVISED ON (B)(6) 2022- APPROXIMATELY 13 YEARS 1 MONTH AFTER IMPLANT. 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; Failure of Implant; Pain

  MAUDE report 19264525 ↗
• InjuryMay 7, 2024Naturally Worn; Naturally Worn

  AS REPORTED, THE 73 YEAR OLD FEMALE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2013. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO POLY ISSUE. THE 9MM SIZE 3 LINER AND 29MM PATELLA WERE REMOVED AND A 9MM SIZE 3 LINER AND 26MM PATELLA WAS IMPLANTED. THERE WAS NO REPORTED BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO IT WAS DISPOSED AT HOSPITAL. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 19259866 ↗
• InjuryMar 21, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD RIGHT KNEE ARTHROPLASTY ON (B)(6) 2014, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 7 YEARS, AND 6 MONTHS, AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO DEVICE INFORMATION PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 18947669 ↗
• InjuryMar 4, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 12.5 YEARS POST INITIAL LEFT TKA, THE 79 Y/O FEMALE PATIENT WAS REVISED DUE TO OSTEOLYSIS AS A RESULT OF POLY WEAR. THE PATIENT WAS REVISED TO A 35MM PATELLA. THE TIBIAL INSERT WAS REVISED TO A SZ 3 FEMORAL COMPONENT AND A SZ3, 11MM TIBIAL INSERT. THERE WAS NO BREAKAGE OF DEVICE. THERE WAS A MORE THAN 45 MINUTES SURGICAL DELAYED DUE TO SURGEON PERFORMED REPLACED THE OPTI FEM WITH A CC LOGIC, STEM + POST 5MM WEDGES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGERS AND X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE IMPLANTS WERE DISCARDED AT HOSPITAL.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 18832835 ↗
• InjuryFeb 28, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2022, APPROXIMATELY 6 YEARS, 9 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: Ambulation or Postural Difficulties; Emotional Changes; Failure of Implant; Inflammation; Joint Laxity; Joint effusion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 18799129 ↗
• InjuryFeb 27, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT A 75 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2007, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 16 YEARS 7 MONTHS POST THE INITIAL PROCEDURE. THE REPORTED INFORMATION INDICATED THE POLY FAILED OVER TIME. THE POLY WAS REVISED TO A 204-23-11 OPTETRAK PS TIBIAL INSERT SZ 3, 11MM. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. NO X-RAYS WERE ABLE TO BE OBTAINED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE IS RETURNING FOR ANALYSIS DUE TO HOSPITAL POLICY. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Failure of Implant

  MAUDE report 18789336 ↗
• InjuryJun 13, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT ON (B)(6) 2013. THEY HAD RIGHT KNEE REVISION ON (B)(6) 2023, APPROXIMATELY 9 YEARS 6 MONTHS AFTER THEIR INITIAL PROCEDURE. THE SPACER WAS COMPLETELY WORN OUT MEDIALLY AND SOMEWHAT LATERALLY, POSTERIORLY. AFTER THE FEMUR WAS TAKEN OUT, THE TIBIA POPPED OUT ON ITS OWN. ALL DEBRIS WAS REMOVED. 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: Failure of Implant

  MAUDE report 17122099 ↗
• InjuryJun 1, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6) 2011. THEIR LEFT KNEE WAS REVISED ON (B)(6) 2022, APPROXIMATELY 11 YEARS 4 MONTHS AFTER THEIR INITIAL PROCEDURE. PATIENT HAS REPORTED SEVERE PAIN, EXTENSIVE SYNOVITIS, LOOSENING, SIGNIFICANT SCARRING, SWELLING, EFFUSION, INFLAMMATION, WEAKNESS, LOSS OF STABILITY AND OTHER INJURIES PRESENTLY UNDIAGNOSED. 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; Failure of Implant; Inflammation; Joint Laxity; Joint effusion; Pain; Scar Tissue; Synovitis

  MAUDE report 17038593 ↗
• InjuryApr 18, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS 78 Y/OFE MALE PATIENT'S RIGHT KNEE WAS REVISED DUE PAIN AND INSTABILITY. ON (B)(6) 2023 REPRESENTATIVE RECEIVED A TEXT CONCERNING A POLY EXCHANGE ON (B)(6) 2023. REP WAS SENT THE X-RAYS AND REALIZED THAT IT WAS THE OLD OPTETRAK PS KNEE THAT THE PATIENT HAD. REP LOOKED UP THE PATIENTS OLD RECORDS THAT REVEALED A SIZE 3 FEMORAL SIZE 3 TIBIAL 32 PATELLA AND A SIZE 3 INSERT. I NOTIFIED SURGEON THAT THEY HAD THE INSTRUMENTS AND POLYS. THEY WENT TO THE O.R. ON (B)(6) 2023 AND REMOVED THE POLY THAT WAS 9MM AND REPLACED IT WITH AN 11MM. EVERYTHING WENT WELL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE NOT RETUNING, PATIENT WANTED THE IMPLANT.

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity

  MAUDE report 16762966 ↗
• InjuryMar 24, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY LEGAL NOTIFICATION, THE FEMALE PATIENT HAD AN INITIAL RIGHT TKA (B)(6) 2012. FOLLOWING A PERIOD OF POST-IMPLANTATION RECOVERY AND FOR YEARS AFTER THE REPLACEMENT SURGERY, THE PATIENT'S EXACTECH KNEE DEVICE PERFORMED AS EXPECTED. ON (B)(6) 2018, THE PATIENT UNDERWENT REVISION OF THE RIGHT EXACTECH KNEE DEVICE SECONDARY TO POLYETHYLENE LINER WEAR WITH RESULTING OSTEOLYSIS, ASEPTIC LOOSENING OF THE TIBIAL COMPONENT, AND DEVELOPMENT OF COMPLEX REGIONAL PAIN SYNDROME.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Failure of Implant; Metal Related Pathology; Osteolysis; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16616387 ↗
• InjuryMar 21, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 79 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2009, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 13 YEARS 7 MONTHS POST THE INITIAL PROCEDURE. THE POLY AND PATELLA WERE REPLACED. POLY ISSUES WITH FLAKING AND DELAMINATION REPORTED. FRAGMENTS OF POLYETHYLENE WERE PRESENT IN THE KNEE JOINT. THE SURGEON REMOVED THE PARTS/PIECES FROM THE PATIENT. THERE WERE NO SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICES RETURNING AS THEY WERE DISCARDED BY THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 16588103 ↗
• InjuryOct 27, 2022Expulsion; Insufficient Device Problem Information; Expulsion; Insufficient Device Problem Information

  AS REPORTED BY LEGAL TEAM, APPROXIMATELY TWELVE YEARS POST INITIAL RIGHT TKA, THE MALE PATIENT HAD A REVISION FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15685910 ↗
• InjurySep 12, 2022Naturally Worn; Naturally Worn

  AS REPORTED, THIS PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2011. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO POLY ISSUES WITH FLAKING AND DELAMINATION. THE SURGEON REPLACED THE PATELLA, POLY AND FEMORAL COMPONENT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. THE DEVICES ARE NOT RETURNING AS THEY WERE DISCARDED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15407598 ↗
• InjurySep 8, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS MALE PATIENT'S LEFT KNEE WAS REVISED 3 YEARS POST OP INITIAL TKA. REASON FOR THE REVISION WAS NOT REPORTED. NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15380864 ↗
• InjuryJul 19, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED A 75 YO MALE, INITIAL IMPLANT DATE (B)(6) 2012, UNDERWENT A LEFT SIDE KNEE REVISION APPROXIMATELY 10 YEARS POST INITIAL IMPLANT DUE TO POLY WEAR. THE POLY WAS EXCHANGED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WERE DISCARDED AND ARE NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15052366 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL BRIEF, ON OR ABOUT (B)(6) 2014, PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT SURGERY IN WHICH AN OPTETRAK SYSTEM WAS IMPLANTED TO TREAT LEFT KNEE DEGENERATIVE JOINT DISEASE. AFTER IMPLANTATION PATIENT EXPERIENCED PAIN AND OTHER SYMPTOMS AND WAS ULTIMATELY DIAGNOSED IN 2021 WITH FAILED LEFT TOTAL KNEE ARTHROPLASTY. ON (B)(6) 2022, AS A DIRECT AND PROXIMATE RESULT THE PATIENT REQUIRED LEFT TOTAL KNEE REVISION SURGERY TO REMOVE FAILED DEVICE AND REPLACE IT WITH A NEW TOTAL KNEE REPLACEMENT SYSTEM.

  Patient problems: Pain

  MAUDE report 14649321 ↗

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-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-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.