SIGMA 1960-01-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295074779), received between Jul 17, 2017 and Nov 21, 2025 — classified as 21 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 reports).

8 other recalls cover devices cleared under the same FDA submission (K241000, K943462); 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND EXCHANGED FOR A COMPONENT AND TIBIA. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23623977 ↗
• InjuryMay 12, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AFTER KNEE SURGERY DUE TO LOOSENING. AFFECTED AREA: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22003738 ↗
• InjuryApr 24, 2024Loss of or Failure to Bond; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  ARTICLE ENTITLED ¿3D POLYETHYLENE WEAR ANALYSIS AFTER PRIMARY CRUCIATE-RETAINING TKA FAILURE USING OPTICAL SCANNING AND CAD MODELS REFERENCES¿ WRITTEN BY MATEJ VALIC, VESNA LEVA¿IC, INGRID MILO¿EV, MATEJA BLAS, EVA PODOV¿OVNIK, JAKA KOREN, AND RIHARD TREB¿E WAS REVIEWED. OUR PURPOSE WAS TO IDENTIFY (A) WHETHER VOLUMETRIC WEAR (ADJUSTED FOR TIME IN-SITU) SIGNIFICANTLY DIFFER AMONG GROUPS OF COMMON CAUSES OF TKA FAILURE, (B) WHETHER THERE IS A CHARACTERISTIC WEAR DISTRIBUTION PATTERN FOR A COMMON CAUSE OF TKA FAILURE, AND (C) WHETHER NOMINAL INSERT SIZE (SMALL VS LARGE) AND COMPONENTS SIZE RATIO (FEMUR-TO-INSERT) INFLUENCE ON VOLUMETRIC WEAR RATES. THE STUDY INCLUDED PATIENTS THAT HAD BEEN IMPLANTED WITH A SIGMA TKA (CEMENTED TIBIAL TRAY AND POROUS COATED FEMORAL COMPONENT). WITHIN THE PATIENT THAT MET THE CRITERIA, THERE WERE NOTED TO BE 86 REVISION CASES DUE TO FAILURE (NO MENTION OF WHY). 59/86 TIBIAL INSERTS WERE RETRIEVED. 2 OF THE 59 INSERTS EXHIBITED INEXPLICABLE ABNORMAL TYPE OF DAMAGE AND WERE EXCLUDED FROM THE FINAL ANALYSIS. FINAL COHORT INCLUDED 57 INSERTS. THERE WAS NO MENTION OF CEMENT MFG OR PATELLA IMPLANTS. RESULTS: 86 REVISIONS. ONLY 5 PATIENTS HAD A SINGLE DETECTED

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 19172260 ↗
• InjuryJul 6, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE SAME SURGERY ON (B)(6) 2023, THE SURGEON ADDRESSED COMPLAINTS OF RIGHT PATELLAR CLUNK BY PERFORMING A SCOPE OF THE RIGHT KNEE. HE IDENTIFIED HYPERTROPHIC SCAR ON THE UNDERSURFACE OF THE QUADRICEPS TENDON, WHICH WAS REMOVED. SCAR WAS ALSO REMOVED AROUND THE PERIPHERY OF THE PATELLA, WHICH ALLOWED THE PATELLA TO TRACK NICELY. NO IMPLANTS WERE REVISED ON THE RIGHT SIDE. DOI: (B)(6) 2016. (B)(6) 2022 (INSERT). DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Unspecified Tissue Injury

  MAUDE report 17265600 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION. EXPLANTED THE FEMORAL COMPONENT SZ 4N SIGMA CR, THE SZ 3 SIGMA FB TRAY, THE SZ 3,8MM FB CURVED INSERT, AND THE PATELLA. CLEAN UP CUTS WERE MADE AND THE SURGEON IMPLANTED AN ATTUNE CR SZ 6 FEMUR WITH AN ALPOLY CR 10MM INSERT AS A TEMPORARY CEMENT MOLD. NOTHING WAS DONE FOR THE PATELLA. NO INJURY TO THE PATIENT AND NO DELAY IN SURGERY. THIS WAS THE PATIENTS RIGHT KNEE. I WAS TOLD THE ORIGINAL SURGERY WAS 12 OR 13 YRS AGO. NO IMPLANT LOG AVAILABLE. DOI: UNK, DOR: (B)(6) 2022, UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 15163082 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR CALF PAIN, VASCULAR DEEP VEIN THROMBOSIS - LEFT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. TREATMENT: ORAL MEDICATION ELIQUIS.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 14488024 ↗
• MalfunctionJun 17, 2021Migration; Migration

  CLINICAL ADVERSE EVENT RECEIVED FOR ASEPTIC LOOSENING OF THE FEMORAL COMPONENT: MIGRATION/LOOSENING - FEMORAL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATE TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2016. DATE OF EVENT (ONSET): (B)(6) 2021 (RIGHT KNEE). ON (B)(6) 2016, THE PATIENT RECEIVED A PFC SIGMA ROTATING PLATFORM KNEE DURING A TOTAL KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. THE PATELLA WAS RESURFACED DURING THE PROCEDURE. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2021, THE PATIENT PRESENTED FOR A RIGHT KNEE EVALUATION DUE TO PAIN, DISCOMFORT, SWELLING, EFFUSION, DECREASED RANGE OF MOTION, AND STIFFNESS. THE PHYSICIAN INDICATED HE WENT BACK TO THE ORIGINAL X-RAY IMAGES AND THE INTERFACE OF THE FEMORAL COMPONENT LOOKED PRISTINE. A COUPLE OF YEARS AGO, THERE WERE SOME MILD INTERFACE CHANGE. NOW X-RAY IMAGES REVEAL A GROSSLY LOOSE FEMORAL COMPONENT. THE PHYSICIAN ASPIRATED 20 ML OF CLEAR, BLOOD-TINGED FLUID FROM THE KNEE AND SENT FOR CULTURE AND GRAM STAIN. THE PHYSICIAN INDICATED THE PATIENT WOULD NEED TO UNDERGO A REVISION OF THE RIGHT KNEE. THERE IS NO EVIDENCE OF A RIGHT KNEE REVISION

  Patient problems: Adhesion(s); Discomfort; Insufficient Information; Loss of Range of Motion; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 12017127 ↗
• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AFTER THE FIRST SURGERY AND TORE A LIGAMENT. THE SURGEON CONVERTED THE FEMUR AND INSERT TO A PS COMPONENT. DOI:(B)(6) 2021. DOR: (B)(6) 2021. RIGHT KNEE.

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

  MAUDE report 11863566 ↗
• InjuryFeb 2, 2021Loss of or Failure to Bond; Noise, Audible; Loss of or Failure to Bond; Noise, Audible

  VOLUNTARY REPORT WAS RECEIVED UNDER MW5098568. PATIENT CONTACTED AND INDICATES SHE WAS EXPERIENCING PAIN, LOOSENING, POPPING, INSTABILITY AND SWELLING WHICH LEAD TO A REVISION. DOI: (B)(6) 2012, DOR: (B)(6) 2018, RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 11266508 ↗
• InjuryJan 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE WAS ALSO REPORTED. A NON-DEPUY CEMENT WAS USED. NO DELAY TO SURGERY REPORTED. DOI: (B)(6) 2018; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11212987 ↗
• MalfunctionDec 17, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT HAPPENED DURING A PRIMARY SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11027191 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2012 INDICATED THAT THE PATIENT RECEIVED A BILATERAL TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. OFFICE NOTES (B)(6) 2020 INDICATED THAT THE PATIENT WAS SEEN AS FOR FOLLOW-UP OF THE RIGHT KNEE. AROUND 5 MONTHS AGO, THE PATIENT EXPERIENCED A SIGNIFICANT HEMARTHROSIS WHICH RESULTED IN ASPIRATION AND DISCONTINUATION OF THE BLOOD THINNER. THE PATIENT WAS STILL EXPERIENCING MILD MID-FLEXION INSTABILITY, AS WELL AS MILD PAIN, SWELLING, STIFFNESS AND POSSIBLE CONTINUED HEMARTHROSIS. TREATMENT AT THIS TIME IS CONTINUED OBSERVATION.

  Patient problems: Joint Laxity; Muscular Rigidity; No Code Available; Pain; Swelling/ Edema

  MAUDE report 10872494 ↗
• InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS STIFFNESS. THE PATIENT UNDERWENT A SIGMA RP CVD CONSTRUCT SEVERAL YEARS AGO. ACCORDING TO THE PATIENT, HE'S NEVER DONE WELL WITH HIS RIGHT KNEE. HIS RIGHT KNEE HAS BEEN FAIRLY STIFF SINCE HIS SURGERY IN 2017. SURGEON ELECTED TO REMOVE THE FEMUR, INSERT, AND TIBIA AND PROCEED WITH A REVISION CONSTRUCT TO RELIEVE SOME OF THE STIFFNESS AND HELP THE PATIENT REGAIN MOTION. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2017. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available

  MAUDE report 10609617 ↗
• InjuryMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 THE PATIENT UNDERWENT A RIGHT CEMENTED TOTAL KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS, END-STAGE, RIGHT KNEE, PAIN, AND MORBID OBESITY. DEPUY COMPONENTS AND CEMENT X1 WERE UTILIZED AND THERE WERE NO COMPLICATIONS NOTED. THE PATELLA WAS RESURFACED. ON (B)(6) 2020 THE PATIENT UNDERWENT A REVISION RIGHT TOTAL KNEE ARTHROPLASTY, SEPTIC ARTHROSIS, ACUTE, SECONDARY TO HEMATOGENOUS SEEDING FROM URINARY INFECTION. IT WAS NOTED THAT PRIOR TO THE REVISION THE PATIENT EXPERIENCED PAIN, DISCOMFORT, AND DYSFUNCTION. THE TIBIAL INSERT WAS REVISED. DURING THE PROCEDURE IT WAS NOTED THAT THE COMPONENTS WERE WELL FIXED, BUT THE KNEE CONTAINED GROSS PUS. THIS IS CAPTURED IN (B)(4). ON (B)(6) 2020 THE PATIENT WAS RECEIVING INTRAVENOUS ANTIBIOTICS STATUS POST I&D. MEDICAL RECORDS FROM (B)(6) 2019 NOTE THAT SIX WEEKS POST RIGHT TOTAL KNEE ARTHROPLASTY WITH WOUND HEALING ISSUE. IT HAD DELAYED HEALING WITH DRAINING. DOE: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 10102729 ↗
• MalfunctionMar 2, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  WHEN OPENING THE IMPLANT BOX THE IMPLANT WAS COVERED WITH FLUFF. A NEW IMPLANT WAS OPENED. THE SURGERY WAS DELAYED FOR ABOUT 10 MINUTES DUE TO THE REPORTED EVENT.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9776059 ↗
• InjuryJan 21, 2020Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION OF RIGHT TKA. SIGMA FB CR. IMPLANTED (B)(6) 2019. INFECTION. BOTH FEMUR AND TIBIA LOOSE, SURGEON DETERMINED THIS WAS A RESULT OF INFECTION. IMPLANTS REMOVED, ANTIBIOTIC SPACERS IMPLANTED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9610877 ↗
• InjuryNov 26, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, ADHESION, POLYETHYLENE WEAR-TYPE SYNOVITIS, STIFFNESS, AND FEMORAL COMPONENT LOOSENING AT AN UNKNOWN INTERFACE. THE SURGEON NOTED THE TIBIAL TRAY AND PATELLA COMPONENT WERE WELL-FIXED. DOI: (B)(6) 2014 DOR: (B)(6) 2019 RIGHT KNEE.

  Patient problems: Adhesion(s); No Code Available; Pain; Synovitis

  MAUDE report 9376076 ↗
• MalfunctionNov 21, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT UPON OPENING THE IMPLANT STERILE CONTAINER THE IMPLANT WAS NOTICED TO HAVE A THICK CLEAR SUBSTANCE ON THE ARTICULATING SURFACE. DOE: UNKNOWN, RIGHT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9353836 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL X-RAYS INDICATING LYSIS AND MICROMOTION: ABNORMAL RADIOGRAPHIC EVALUATION EVENT IS SERIOUS AND IS CONSIDERED MODERATE, AND IS AWAITING REVISION EVENT IS DEFINITELY RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THAT IT IS RELATED TO PROCEDURE. DOI: (B)(6) 2015. DOE: (B)(6) 2019. (RIGHT KNEE).

  Patient problems: No Code Available

  MAUDE report 9290010 ↗
• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS KNEE PAIN AND WHAT WAS ASSUMED TO BE FEMORAL LOOSENING. THE FEMUR WAS NOT LOOSE BUT WAS REMOVED. THE INSERT AND PATELLA WERE ALSO REMOVED. THE TIBIA WAS WELL FIXED AND RETAINED. A NEW SIGMA SIZE 3 TC3 FEMUR, AUGMENTS, CEMENTED STEM, INSERT AND PATELLA WERE IMPLANTED. PATIENT HAS A SIGMA RP CR CEMENTED KNEE IMPLANTED IN 2015. DOI: (B)(6) 2015. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9266105 ↗
• MalfunctionSep 25, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  CLINICAL ADVERSE EVENT RECEIVED FOR ASEPTIC LOOSENING OF THE FEMUR: ABNORMAL RADIOGRAPHIC EVALUATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014. DATE OF EVENT: (B)(6) 2019, (RIGHT KNEE).

  Patient problems: Edema; No Consequences Or Impact To Patient; Pain

  MAUDE report 9119317 ↗
• MalfunctionSep 24, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  CUSTOMER SENT AN IMPLANT TO DOT TO HAVE IT COATED WITH TINI. AT INCOMING INSPECTION, DOT FOUND IMPLANT´S LOT NUMBER ON THE PATIENT LABEL DOES NOT MATCH WITH (LOT?-) NUMBER ETCHED TO THE FEMORAL IMPLANT. NO SURGERY DELAY, NO ADVERSE CONSEQUENCES FOR PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9109547 ↗
• MalfunctionJan 21, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING THE CASE ON, 2.5 SIZER CAME OUT OF THE 4 SIZER BOX. THE 196001400 CODED DEVICE WAS IN CONSIGNMENT. IT'S UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8264588 ↗
• InjurySep 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SUBJECT: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR DISRUPTION OF THE ARTHROTOMY REPAIR, STATUS POST RIGHT TOTAL KNEE, WITH PATELLAR SUBLUXATION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. TREATMENT INCLUDES IRRIGATION AND DEBRIDEMENT WITH LATERAL RELEASE AND REPAIR OF MEDIAL ARTHROTOMY. DOI: (B)(6) 2018; DOE: 03/23/2018; (RIGHT KNEE).

  Patient problems: Joint Dislocation; No Code Available; Pain

  MAUDE report 7898820 ↗
• InjuryJul 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND STIFFNESS. DOI: (B)(6) 2015; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 7732080 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K943462. One submission often covers many models, so check the product and lot details in each record.

• Z-1077-2014 · Dec 9, 2013 · Terminated
  PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
• Z-1686-2009 · May 7, 2009 · Terminated
  DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, DePuy Orthopaedics, Inc., Warsaw, IN; REF 96-0005. The devic
• Z-0403-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 3, 8 mm, 71mm M/L, 47 mm A/P, UHMWPE, sterile; Product Code/ REF 96-0640.
• Z-0406-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 4, 10mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0651.
• Z-0407-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 5, 15mm, 83mm M/L, 55mm A/P, UHMWPE, sterile; Product Code/REF 96-0663.
• Z-0405-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 4, 8mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0650.
• Z-0404-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 3, 10mm, 71mm M/L, 47mm A/P, UHMWPE, sterile; Product Code/REF 96-0641.
• Z-0402-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 2.5, 8 mm, 67mm M/L, 45 mm A/P, UHMWPE, 2.5, sterile; Product Code/REF 96-0630.