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 D
Check against the official notice below — it lists the full affected range.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa. Quantity: 12,156 US Lot/code info: 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 C-MM100520-04 No UDI Lot 195082 C-MM100520-02 No UDI Lot 195080 C-MM100411-03 No UDI Lot 194962 C-MM100411-04 No UDI Lot 194963 C-MM100411-02 No UDI Lot 194961 C-MM100507-04 No UDI Lot LNH795 C-MM100507-06 No UDI Lot LNH797 C-M071-6-601 No UDI Lot G3055684 C-M113-5-603 No UDI Lot 194594 C-M067-3-103 No UDI Lot MHP0AX C-M107-7-801 No UDI Lot 193479 C-M064-4-300 No UDI Lot RX06443A C-M067-5-003 No UDI Lot RX06750D C-M067-5-002 No UDI Lot RX06750C C-M066-0-901 No UDI Lot RX06609B C-M104-2-002 No UDI Lot 192371 C-M104-2-003 No UDI Lot 192370 UH1-38-22 UDI-DI 07613327016789 Lots 2A01TA 430715 49510K 7E5X23 852J98 D23664 NE659N UH1-40-22 UDI-DI 07613327016796 Lots 128LXW 16182H 1J5955 1T8203 2137N4 2541YM 2Y52Y2 4E19VD 4K7XYL 577M4L 5D3AVR 746AV4 7V8J0V 828TAR 875M72 8V63LX 9A3W5N A91P07 DL4D38 LW709R RA6A1H VT4K59 X95RTV UH1-41-22 UDI-DI 07613327016819 Lots 343653 4P1TR7 521MLK 7Y8HEA 975A6Y AR0KX5 E788E6 KL1YTE KN0086 P043ME PL4L5M UH1-42-22 UDI-DI 07613327016833 Lots 1R2VD1 2E84HD 2X333W 4L5YMY 6J2W2P 7238R2 7883W1 7H2L8M 8K315D AK2P91 ET3HWR L16J85 L93PY2 ME1485 MY1N20 P987D0 R92PDW TM0
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.