Optetrak Logic 02-012-35-2011Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10885862001733), received between Aug 18, 2020 and Sep 12, 2025 — classified as 70 injuries.

The most frequently reported specific device problem is “Naturally Worn” (60 reports).

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

2 other recalls cover devices cleared under the same FDA submission (K033883); 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-0021-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2025Naturally Worn; Naturally Worn

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY 8 YEARS AND 8 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT EXPERIENCED POLYETHYLENE WEAR WITH EVIDENCE OF OSTEOLYSIS, AND MILD LUCENCY UNDERNEATH THE KNEECAP. OTHERWISE, NO IMMEDIATE CONCERNS. WILL CONTINUE TO MONITOR; APPOINTMENT IN 12 MONTHS WITH X-RAY ON ARRIVAL. THE OUTCOME IS CONTINUING.

  Patient problems: Osteolysis

  MAUDE report 23036891 ↗
• InjuryJul 28, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS AND 8 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO POLYETHYLENE WEAR WITH MASSIVE FEMORAL AND TIBIAL OSTEOLYSIS. ONLY THE INSERT WAS REVISED. THE PATIENT WAS REVISED TO A COMPETITOR DEVICE.

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 22629086 ↗
• InjuryJul 1, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE LEFT SIDE. 5.5 YEARS FOLLOWING, THE PATIENT EXPERIENCED ASEPTIC PATELLA LOOSENING AND LYSIS AROUND THE PATELLA BUTTON WITH DISPLACED FRAGMENTATION OF THE SUPERIOR POLE AND WAS REHABILITATING THROUGH QUADRICEPS EXERCISES. SUBSEQUENTLY, THE PATIENT NOW IS EXPERIENCING POLYETHYLENE WEAR WITH EVIDENCE OF OSTEOLYSIS TO LEFT KNEE. AS A RESULT, APPROXIMATELY 6.5 YEARS AFTER INITIAL REPLACEMENT, ARTHROSCOPY AND DEBRIDEMENT WITH BIOPSY (DAY CASE) WAS PERFORMED TO LEFT KNEE OF THE PATIENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE. THIS IS 1 OF 3 EVENTS FOR THIS PATIENT.

  Patient problems: Osteolysis

  MAUDE report 22378634 ↗
• InjuryMay 13, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED APPROXIMATELY 175 MONTHS POST A RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT PRESENTED WITH PAIN AND APPROXIMATELY A WEEK LATER UNDERWENT SCHEDULED A SECOND RIGHT KNEE REVISION PROCEDURE OF THE FEMORAL COMPONENT INSERT AND PATELLA COMPONENTS. IT WAS NOTED THE INSERT AND PATELLA WERE REPLACED DUE TO RECALLS AND THE FEMORAL COMPONENT WAS SIGNIFICANTLY LOOSE. PICTURES OF THE EXPLANTS WERE PROVIDED. THERE WERE NO SURGICAL DELAYS OR MEDICAL INTERVENTIONS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22009551 ↗
• InjuryApr 24, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 12.5 YEARS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT COMPLAINED OF PAIN. THE PATIENT UNDERWENT A REVISION DUE TO A LOOSE FEMUR AND RECALLED POLY. THERE WAS NO REPORTED BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 21902762 ↗
• InjuryNov 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 35 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 20707194 ↗
• InjuryOct 14, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ (B)(4). (B)(4) IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 99 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022. (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20440309 ↗
• InjuryOct 4, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA. IT WAS REPORTED THAT APPROXIMATELY 103 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR RIGHT KNEE PAIN, LARGE LATERAL OSTEOPHYTE ON PATELLA. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

  Patient problems: Pain

  MAUDE report 20376057 ↗
• InjurySep 30, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 8 YEARS AND 8 MONTHS POST THE INITIAL RIGHT TKA, THE PATIENT WAS REVISED DUE TO SUSPECTED OXIDATION OF THE KNEE POLY. THE PATIENT WAS REVISED TO E-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: Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 20332886 ↗
• InjurySep 24, 2024Naturally Worn; Lack of Effect; Naturally Worn; Lack of Effect

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 56 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, JOINT PAIN, JOINT SWELLING AND STIFFNESS, LIMITED ROM, LOSS OF MOBILITY, REVISION SURGERY, POLYETHYLENE WEAR, CONSTRAINED LINER REVISION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20292869 ↗
• InjurySep 4, 2024Naturally Worn; Naturally Worn

  THE FOLLOWING ACTIONS WERE TAKEN: APPROXIMATELY 5 YEARS AND 9 MONTHS POST-OP THE PATIENT UNDERWENT ARTHROSCOPY AND DEBRIDEMENT WITH A BIOPSY. APPROXIMATELY 8 MONTHS LATER, THE PATIENT WAS REVIEWED IN CLINIC AND HAS BEEN LISTED FOR REVISION OF THE RIGHT KNEE +/- POLY EXCHANGE ALONE. FINALLY, THE PATIENT UNDERWENT REVISION SURGERY IN LATE SUMMER OF 2023. THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED AND THE CLINICAL STUDY REPORT INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE AND DEFINITELY NOT RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Swelling/ Edema

  MAUDE report 20137569 ↗
• InjurySep 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 81 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SUFFERING, LOSS OF EARNING CAPACITY, MENTAL AND EMOTIONAL STRESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Pain

  MAUDE report 20134585 ↗
• InjuryAug 28, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 143 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, EFFUSION AND PAIN.

  Patient problems: Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 20088766 ↗
• InjuryAug 23, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 122 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS SIGNIFICANT POLY WEAR, SIGNIFICANT SYNOVITIS, OSTEOLYSIS AND PAIN/INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 20052152 ↗
• InjuryAug 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 160 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19982728 ↗
• InjuryAug 9, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 168 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAROSTEOLYSIS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Loss of Range of Motion; Osteolysis; Swelling/ Edema

  MAUDE report 19948866 ↗
• InjuryAug 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 120 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19928250 ↗
• InjuryJun 10, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 17 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. (B)(4) REVISED RK REVISION, (B)(4) LK REVISION, (B)(4) REVISED LK REVISION IS ASSOCIATED WITH THIS CASE.

  Patient problems: Failure of Implant; Implant Pain; Insufficient Information; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 19498070 ↗
• InjuryMay 20, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 167 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, INSTABILITY, BONE LOSS, AND OSTEOLYSIS. 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: Failure of Implant; Implant Pain; Joint Laxity; Joint effusion; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 19353740 ↗
• InjuryMay 3, 2024Unstable; Material Deformation; Naturally Worn; Unstable; Material Deformation; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 102 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, SWELLING, AND INSTABILITY. THE REVISING SURGEON NOTED BONE DAMAGE AND CANCELLOUS BONE LOSS IN THE FEMORAL CONDYLE AND TIBIAL PLATEAU AND NOTED OSTEOLYSIS OF INTERNAL PROSTHETIC LEFT KNEE JOINT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19242691 ↗
• InjuryApr 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2017 AND THEN WAS REVISED ON (B)(6) 2023. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE PROSTHESIS WEAR, PAIN, COMPONENT LOOSENING AND DEVICE FAILURE. THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED. PER THE OPERATIVE REPORT FOR REVISION, DESCRIPTION OF THE INITIAL SURGERY COMPONENTS WAS PROVIDED AND THE FEMORAL COMPONENT WAS FOUND TO BE GROSSLY LOOSE FOR THE CEMENT MANTLE AND THERE WAS A MODERATE AMOUNT OF OSTEOLYSIS BEHIND THE CEMENT MANTLE. THE TIBIAL COMPONENT WAS FOUND TO BE WELL FIXED TO BONE AND THE PATELLAR COMPONENT WAS WELL FIXED. THERE WAS A MODERATE AMOUNT OF VISIBLE AND PALPABLE POLYETHYLENE WEAR WITHIN THE TIBIAL POLYETHYLENE COMPONENT.

  Patient problems: Failure of Implant; Osteolysis; Scar Tissue

  MAUDE report 19184629 ↗
• InjuryApr 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 9 YEARS AND 8 MONTHS AFTER INITIAL IMPLANT. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19132059 ↗
• InjuryApr 16, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 6 YEARS AND 1 MONTHS AFTER INITIAL IMPLANT. OP REPORT - POSTOPERATIVE DIAGNOSIS; POLY WEAR AND ASEPTIC LOOSENING NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 19114162 ↗
• InjuryApr 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 11 YEARS AND 2 MONTHS AFTER INITIAL IMPLANT. THERE IS NO DEVICE INFORMATION PROVIDED. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE 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 19049115 ↗
• InjuryMar 26, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON 10 OCT 2011 AND THEN APPROXIMATELY 10 YEARS 3 MONTHS LATER, ON (B)(6) 2021 SHE EXPERIENCED A SURGICAL REVISION. REVISION OPERATIVE REPORT OF (B)(6) 2021- POSTOPERATIVE DIAGNOSIS: LOOSE PLASTIC SPACER, DEBRIS SYNOVITIS, STABLE FEMUR, STABLE TIBIA, STABLE PATELLA WITH LOCAL CYSTIC FORMATION IN TIBIA. NAME OF OPERATION: ARTHROTOMY, EVALUATION KNEE REPLACEMENT, REVISION SPACER, PARTIAL SYNOVECTOMY, REMOVAL OF DEBRIS SYNOVITIS, REMOVAL OF SCAR TISSUE. THE PATIENT HAD GROSS DEBRIS SYNOVITIS THROUGHOUT THE KNEE. THE PLASTIC SPACER WAS LOOSENED WHEN THE KNEE WAS PUT INTO FLEXION; IT WAS REMOVED. THE PATIENT DID HAVE SIDE-TO-SIDE PLAY CONSISTENT WITH PLASTIC DEBRIS WEAR. THE TIBIA, THE FEMUR AND THE PATELLA WERE ALL STABLE. THEY WERE NOT LOOSE BY MECHANICAL EVALUATION AND VISUAL INSPECTION. THE PATIENT DID HOWEVER HAVE TWO AREAS ON THE TIBIA WHERE WERE EROSION OF THE CORTEX, ONE MEDIAL AND ONE ANTERIOR WITH BONE IN BETWEEN INTACT. THE FEMUR AND PATELLA DID NOT SHOW THE SAME PHENOMENON. IT WAS ELECTED TO JUST CHANGE THE PLASTIC SPACER FROM AN 11 TO A 13. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. NO

  Patient problems: Cyst(s)

  MAUDE report 18983568 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033883. One submission often covers many models, so check the product and lot details in each record.

• Z-0584-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
• 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