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RecallWatchMedical Device Safety
Class IIOngoingZ-3199-2026

Howmedica Osteonics Corp. recalls ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR…

Howmedica Osteonics Corp.Mahwah, NJ, United StatesReported Sep 23, 2026 · 6 days ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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 100520 C-MM100520-04 GMRS SML POLY TIBIA 8MM CASE 100520 C-MM100520-02 GMRS SML TIBIA 11MM WITH CASE 100411 C-MM100411-03 GMRS SML TIBIA 14MM WITH CASE 100411 C-MM100411-04 GMRS SML TIBIA 8MM WITH CASE 100411 C-MM100411-02 GMRS TIB INSRT SML 10MM WITH CASE 100507 C-MM100507-04 GMRS TIB INSRT SML 16MM WITH CASE 100507 C-MM100507-06 KALI TIBIAL INSERT LARGE RIGHT 8mm C-M071-6-601 KRH REV TIB INS 16mm THK .655 DIA STEM C-M113-5-603 MRH KNEE TIBIAL INSERT FOR THIN POST C-M067-3-103 MRS RADIAL BUSHING FORITH C-M107-7-800 C-M107-7-801 SELF-PRESSURIZING GLENOID SIZE 9 C-M064-4-300 TRIATHLON NO. 9 TIBIAL INSERT 11MM C-M067-5-003 TRIATHLON NO. 9 TIBIAL INSERT 9MM C-M067-5-002 TRIDENT ALL POLY CUP 44 X 66MM C-M066-0-901 TRIDENT CONSTRAINED ACETABULAR INSERT SIZE A X 22mm ID UH1 C-M104-2-002 TRIDENT CONSTRAINED ACETABULAR INSERT SIZE B X 22mm ID UH1 C-M104-2-003 UHR BIPOLAR 22X38MM UH1-38-22 UHR BIPOLAR 22X40MM UH1-40-22 UHR BIPOLAR 22X41MM UH1-41-22 UHR BIPOLAR 22X42MM UH1-42-22 UHR BIPOLAR 22X43MM UH1-43-22 UHR BIPOLAR 22X45MM UH1-45-22 UHR BIPOLAR 26X41mm UH1-41-26 UHR BIPOLAR 26X42mm UH1-42-26 UHR BIPOLAR 26X43mm UH1-43-26 UHR BIPOLAR 26X44mm UH1-44-26 UHR BIPOLAR 26X45mm UH1-45-26 UHR BIPOLAR 26X46mm UH1-46-26 UHR BIPOLAR 26X47mm UH1-47-26 UHR BIPOLAR 26X48mm UH1-48-26 UHR BIPOLAR 28X42mm UH1-42-28 UHR BIPOLAR 28X44mm UH1-44-28 UHR BIPOLAR 28X45mm UH1-45-28 UHR BIPOLAR 28X46mm UH1-46-28 UHR BIPOLAR 28X47mm UH1-47-28 UHR BIPOLAR 28X48mm UH1-48-28 Orthopaedic implant components manufactured from UHMWPE (polyethylene)C-M079-2
    UDI-DI 07613327504811
    400 affected lots
    G3264034C-M071-6-700G3043883C-M071-8-400G3043878C-M110-1-20107613327504811573P37
    +392 moreC-MM100253-02N8873HC-M066-3-000RX06630AC-M082-7-303L6237C-M107-5-301193607C-MM100616-02195261C-MM100616-03195262C-MM100616-01195260C-MM100520-03195081C-MM100520-04195082C-MM100520-02195080C-MM100411-03194962C-MM100411-04194963C-MM100411-02194961C-MM100507-04LNH795C-MM100507-06LNH797C-M071-6-601G3055684C-M113-5-603194594C-M067-3-103MHP0AXC-M107-7-801193479C-M064-4-300RX06443AC-M067-5-003RX06750DC-M067-5-002RX06750CC-M066-0-901RX06609BC-M104-2-002192371C-M104-2-003192370UH1-38-22076133270167892A01TA43071549510K7E5X23852J98D23664NE659NUH1-40-2207613327016796128LXW16182H1J59551T82032137N42541YM2Y52Y24E19VD4K7XYL577M4L5D3AVR746AV47V8J0V828TAR875M728V63LX9A3W5NA91P07DL4D38LW709RRA6A1HVT4K59X95RTVUH1-41-22076133270168193436534P1TR7521MLK7Y8HEA975A6YAR0KX5E788E6KL1YTEKN0086P043MEPL4L5MUH1-42-22076133270168331R2VD12E84HD2X333W4L5YMY6J2W2P7238R27883W17H2L8M8K315DAK2P91ET3HWRL16J85L93PY2ME1485MY1N20P987D0R92PDWTM0KR0X884ETXD3961YK39TTUH1-43-220761332701684011138V23005R481KR9516JLV761T5M9W3NWVDA0W51EK6069KP0AADMD1Y5VNT68KLRT8N8HRY828PUH1-45-22076133270169018Y0KWHHR869MR7168KWR4MT4UH1-41-2607613327016802157V1T1D33YX1K1E6M1R5LWT218RED254MT3287D4A2K7HXW2X5MTA3J1A393K3P0T473K4V5A1T5N5D6KJ55V7H826J8XKT6W1MKA8R29TH9T7N8YAL5K8MAW02V8DT8JEWH04PHLJR6R9LLN70PYMA6M6EPE7T6PPY8PLHRY49EWT1497XV70PNPVJ6WXMX82M1DUH1-42-2607613327016826186JE65Y1RL7618AMX7J0XETMLKT5AMLL022MLL05KR50NW2UH1-43-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-44-2607613327016888336652581XTY5H1YRH640Y4R7Y7H149J7T4LA881HXJN7TXMKT4P91LJ44JXM52APNMLL2PTMLL5X1MLLD4RMLLPK1MLLV2YNR773KNV0NVXPD7P36R74D1DT31P16VK7JL5W91ENEXD45XYXN8EWLY385N4YN1AJNUH1-45-2607613327016925056MNE059MNE188AWK243WTY352XY0442K1P8L58NKAJ0H2RAN15H5HX6PARHY2V81L50T23MLL0AEMLL5J4MLL9TVN88PKJP31A9YRJ8JPRUH1-46-26076133270169491839Y21M2AX31P2E821V5AN9226AWD232X832465J72K0P932R3XD63614YL394D8M3P70914V2PVP5389M05N2N759X7YK5A35V7KDW3J8WDY85VAE242NYH07J22JV88X1L04PPVLY44K5MLL50MMLL789MLLA53NE45DDV94NTTYY5N98UH1-47-26076133270169871Y2K3421197T3E0A484E7MKW7K1VLWA58HN9J38RE2J60A4ELT43X0M15HKNMK442YMLL2LRMLL52NXD724JUH1-48-26076133270170071J8K9L2Y6JK3350D6V3845V33D621644827N580Y68726W7P7L7TPP8E7A1J9V8P949Y6HMLH88E74K54MN4L783M7MLL3E9MLL52WMP56YNN00HDAN26TW7TR4TT5W016KY

What the firm is doing

Firm began notifying customers on July 30, 2026, via FedEx 2-day air. Customers were instructed to quarantine and discontinue use of the affected product. Affected product should be returned to the firm.

DistributionShow details

Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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