United StatesVarious Howmedica Osteonics orthopaedic implant components made from ultra‑high‑molecular‑weight polyethylene (UHMWPE) — including AXLE PIN ASSY LARGE ELBOW (Catalog C‑M112‑2‑500) and numerous acetabular, tibial, patella and hinge inserts identified by the catalog numbers and lot numbers listed in the notice — are affected. They were manufactured with UHMWPE raw material aged more than five years, which can cause elevated oxidation and increased wear that may lead to excessive wear debris, material fragments, fractured or disassociated devices and potential harms such as revision surgery, pain, or inflammation.
What's being recalled
AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SCORPIO INSET PATELLA 73-2610 SCORPIO M-DOME PATELLA 73-0110 73-0710 73-0910 SCORPIO RECESSED PATELLA 26MM 3044-0026 SCORPIO TS TIB INS 72-4-9114 SCORPIO TS TIBIAL INSERT 72-4-0324 SCORPIOFLEX TOTAL KNEE CR 72-16-0512 72-16-0518 72-16-0912 72-16-1112 SERIES II TIBIAL BEAR INSERT NO 11 15MM 3052-1115 UHR BIPOLAR 26X52mm UH1-52-26 UHR BIPOLAR 26X58mm UH1-58-26 UHR BIPOLAR 28X48mm UH1-48-28 UHR BIPOLAR 28X52mm UH1-52-28 UHR BIPOLAR 28X55mm UH1-55-28 UHR BIPOLAR 32X49MM UH1-49-32 UHR BIPOLAR 32X51MM UH1-51-32 UHR BIPOLAR…
TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD C-M071-8-400 BEARING AND AXLE BUSHING ASSY STANDARD ELBOW C-M110-1-201 BUSHING AND BEARING USE C-MM100253-00 C-MM100253-02 DURACON TIB INSERT LG 12MM MED 14MM LAT C-M066-3-000 EXETER WINGLESS CENTRALISER FOR C-M082-7-302 C-M082-7-303 EXETER WINGLESS CENTRALIZER XSM C-M107-5-301 GMRS EXTRA SM ALL-POLY TIBIA SIZE 11mm C-MM100616-02 GMRS EXTRA SM ALL-POLY TIBIA SIZE 16mm C-MM100616-03 GMRS EXTRA SM ALL-POLY TIBIA SIZE 8mm C-MM100616-01 GMRS SML POLY TIBIA 11MM CASE 100520 C-MM100520-03 GMRS SML POLY TIBIA 16MM CASE…
DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-800 C-M062-7-500 C-M063-2-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-000 SHOULDER - GLENOID #11 5361-6111 SHOULDER - GLENOID #5 5361-6105 SHOULDER - GLENOID #7 5361-6107 SHOULDER - GLENOID #9 5361-6109 SHOULDER - KEELED GLENOID #11 5361-6211 SHOULDER - KEELED GLENOID #5 5361-6205 SHOULDER - KEELED GLENOID #7 5361-6207 SHOULDER - KEELED GLENOID #9 5361-6209 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL POLY CONSTRAINED INSERT 50MM 69-2850 ALL POLY CONSTRAINED INSERT 52MM 69-2852 CONSTRAINED ACETABULAR INSERTS 22MM 50MM 2099-2250 CONSTRAINED ACETABULAR INSERTS 22MM 52MM 2099-2252 CONSTRAINED ACETABULAR INSERTS 22MM 56MM 2099-2256 CONSTRAINED ACETABULAR INSERTS 28MM 61MM 2099-2861 EIUS UNI TIB SMALL RM/LL 9MM 6636-0-419 PCA CONST LINER 32MM NEUTRAL C - SHELL 6299-N-332 SYS 12 CONST LINER 32ID 10 DEG P6 +4MM 6302-H-632 TRIDENT 0 DEG CONSTRAINED INSERT 22D 690-00-22D TRIDENT 0 DEG CONSTRAINED INSERT 22E 690-00-22E TRIDENT 0 DEG…
BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM C-M113-5-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-800 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)
SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322 SYSTEM ONE BIPOLAR 44MM 6074-4422 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Recalling firm: Howmedica Osteonics Corp., Mahwah, NJ, United States.
How to identify it
No UDI-DI Lot P22E159 UDI-DI 07613327037883 Lot 13MFT 69-2854 UDI-DI 07613327025491 Lots MLKY8A MLL8E1 82-2-0512 UDI-DI 04546540400611 Lot 23325151 82-2-0518 UDI-DI 04546540400635 Lot 23640051 82-2-0912 UDI-DI 04546540400758 Lot 26862851 82-3-0318 UDI-DI 04546540364319 Lot 28208551 78-5-0910 UDI-DI 07613327366006 Lots 30582401 30582601 73-2710 UDI-DI 07613327033847 Lot 14HDSA 73-2610 UDI-DI 07613327014082 Lots 193307A 193307E 73-0110 UDI-DI 07613327050288 Lot HHPW 73-0710 UDI-DI 07613327050295 Lots 8P83 DL4V 73-0910 UDI-DI 07613327050332 Lot 14NACD 3044-0026 UDI-DI 07613327033779 Lots 14SCVA 14SCVD 14SCVF 72-4-9114 UDI-DI 07613327034875 Lot 8H39KP 72-4-0324 UDI-DI 07613327034356 Lot 23505751 72-16-0512 UDI-DI 07613154020515 Lots 17376651 19093651 23125951 27835951 72-16-0518 UDI-DI 07613154020539 Lot 25621551 72-16-0912 UDI-DI 07613154020652 Lot 17879451 72-16-1112 UDI-DI 07613154020737 Lot 22764851 3052-1115 UDI-DI 07613327034240 Lot MJ7YY6 UH1-52-26 UDI-DI 07613327017168 Lot 5J8PM2 UH1-58-26 UDI-DI 07613327017359 Lots 1R8TNH 414A2L 4W1HD7 AV0J7J E226XA E50DAW M31665 WK1WP2 X90ML6 UH1-48-28 UDI-DI 07613327017014 Lots N046DW N06WWP N20WDM N75AY1 P419XW RP3D0X TD218R V15WA1 VH06PA VN3P18 VR853H WM8KJT XE2ND8 YH0N93 UH1-52-28 UDI-DI 07613327017182 Lot V02MME UH1-55-28 UDI-DI 07613327017281 Lot R30MME UH1-49-32 UDI-DI 07613327017069 Lot 324H9H UH1-51-32 UDI-DI 07613327017120 Lot 9J6N9E UH1-52-32 UDI-DI 07613327017212 Lots 5D4NMJ 9T612E UH1-54-32 UDI-DI 07613327017267 Lot MNNAAL 5612-P-411 UDI-DI 07613327601893 Lot 360958 5612-P-413 UDI-DI 07613327602012 Lot 354573 C-M079-2-801 No UDI Lot G3264034 C-M071-6-700 No UDI Lot G3043883 C-M071-8-400 No UDI Lot G3043878 C-M110-1-201 UDI-DI 07613327504811 Lot 573P37 C-MM100253-02 No UDI Lot N8873H C-M066-3-000 No UDI Lot RX06630A C-M082-7-303 No UDI Lot L6237 C-M107-5-301 No UDI Lot 193607 C-MM100616-02 No UDI Lot 195261 C-MM100616-03 No UDI Lot 195262 C-MM100616-01 No UDI Lot 195260 C-MM100520-03 No UDI Lot 195081…
The hazard
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)