Class II U.S. Food and Drug Administration

Howmedica Osteonics Corp. ABG I Acetabular Insert Hooded 28mm ID X 48mm C-M079-2-801 recall: Affected devices were manufactured with Ultra High Molecular Weight

Recall published last month

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.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3199-2026
Published
September 23, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Howmedica Osteonics Corp.
Product type
Medical devices
Units affected
12,156 US
Distribution
Nationwide
Made in
United States
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 TM0KR0 X884ET XD3961 YK39TT UH1-43-22 UDI-DI 07613327016840 Lots 11138V 23005R 481KR9 516JLV 761T5M 9W3NWV DA0W51 EK6069 KP0AAD MD1Y5V NT68KL RT8N8H RY828P UH1-45-22 UDI-DI 07613327016901 Lots 8Y0KWH HR869M R7168K WR4MT4 UH1-41-26 UDI-DI 07613327016802 Lots 157V1T 1D33YX 1K1E6M 1R5LWT 218RED 254MT3 287D4A 2K7HXW 2X5MTA 3J1A39 3K3P0T 473K4V 5A1T5N 5D6KJ5 5V7H82 6J8XKT 6W1MKA 8R29TH 9T7N8Y AL5K8M AW02V8 DT8JEW H04PHL JR6R9L LN70PY MA6M6E PE7T6P PY8PLH RY49EW T1497X V70PNP VJ6WXM X82M1D UH1-42-26 UDI-DI 07613327016826 Lots 186JE6 5Y1RL7 618AMX 7J0XET MLKT5A MLL022 MLL05K R50NW2 UH1-43-26 UDI-DI 07613327016864 Lots 192J0R 1D45L5 1H5V53 2P2A99 2V6D0R 3248V2 334851 386P0V 3N33VT 402RP3 4644KD 4J5Y6H 4L3JPP 5H1A45 5Y2422 626J60 6E33NR 6J30X2 6M2KK8 6V092N 761EJP 7820L1 791NPH 7D0H4K 7K28Y8 7K63EE 7N7WX1 817AJJ 8J6TAL 8L6R73 8T3XDK 983JDR 998H5N 9E631T A93KWD AY40L3 DJ105H E521L6 EX5DA9 HW7XYK J94M7R JT565R JX0L8R K939KP KA30HV KE5770 KP1Y0E KV3L3H MD76WR MJ1DY9 MK2MN3 MLL54K MLL65N MLLV64 MR6D42 MW2J8W N314DK NP48X0 P147V0 P502R8 P92DV1 RL1TL1 RN8NM1 T66JK4 TA20N9 TT3EJR TV197Y TY7YV5 V68NXH V91EK1 VW74NJ VX5T02 VY0525 WA0VRE WT7P1A X48P1Y Y63LYJ Y648WL YE3W2X YJ6PHM YL3HVY YL6L7K YX8NTJ UH1-44-26 UDI-DI 07613327016888 Lots 336652 581XTY 5H1YRH 640Y4R 7Y7H14 9J7T4L A881HX JN7TXM KT4P91 LJ44JX M52APN MLL2PT MLL5X1 MLLD4R MLLPK1 MLLV2Y NR773K NV0NVX PD7P36 R74D1D T31P16 VK7JL5 W91ENE XD45XY XN8EWL Y385N4 YN1AJN UH1-45-26 UDI-DI 07613327016925 Lots 056MNE 059MNE 188AWK 243WTY 352XY0 442K1P 8L58NK AJ0H2R AN15H5 HX6PAR HY2V81 L50T23 MLL0AE MLL5J4 MLL9TV MLLKNT N88PKJ P31A9Y RJ8JPR UH1-46-26 UDI-DI 07613327016949 Lots 1839Y2 1M2AX3 1P2E82 1V5AN9 226AWD 232X83 2465J7 2K0P93 2R3XD6 3614YL 394D8M 3P7091 4V2PVP 5389M0 5N2N75 9X7YK5 A35V7K DW3J8W DY85VA E242NY H07J22 JV88X1 L04PPV LY44K5 MLL50M MLL789 MLLA53 NE45DD V94NTT YY5N98 UH1-47-26 UDI-DI 07613327016987 Lots 1Y2K34 21197T 3E0A48 4E7MKW 7K1VLW A58HN9 J38RE2 J60A4E LT43X0 M15HKN MK442Y MLL2LR MLL52N MLLRMW MLLVRW MLLWVH XD724J UH1-48-26 UDI-DI 07613327017007 Lots 1J8K9L 2Y6JK3 350D6V 3845V3 3D6216 44827N 580Y68 726W7P 7L7TPP 8E7A1J 9V8P94 9Y6HML H88E74 K54MN4 L783M7 MLL3E9 MLL52W MP56YN N00HDA N26TW7 TR4TT5 W016KY XJ48DN YA4YPN UH1-42-28 UDI-DI 07613327016857 Lots 1R5MDV 275NEA 2V6KMY 4215LV MLKEHT MLLJ5X MLLJK9 MLLV75 UH1-44-28 UDI-DI 07613327016895 Lots 106X12 121A72 123MX4 138KNV 1401YE 1429X2 154N34 1740KE 1830AR 186WEL 1D8LYA 1E4HK2 1E6W32 1E7RRN 1H1P69 1K10H5 1K58A6 1K63LK 1M1W89 1M6JWR 1N6VPP 1R8333 1V4LXR 1X8R7X …
UPC codes
07613327504811, 07613327016789, 07613327016796, 07613327016819, 07613327016833, 07613327016840, 07613327016901, 07613327016802, 07613327016826, 07613327016864, 07613327016888, 07613327016925, 07613327016949, 07613327016987, 07613327017007, 07613327016857, 07613327016895

Products covered by this recall

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)

Check your product

The notice names 19 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 07613327504811
  • 07613327016789
  • 07613327016796
  • 07613327016819
  • 07613327016833
  • 07613327016840
  • 07613327016901
  • 07613327016802
  • 07613327016826
  • 07613327016864
  • 07613327016888
  • 07613327016925
  • 07613327016949
  • 07613327016987
  • 07613327017007
  • 07613327016857
  • 07613327016895

Package size

Match the net weight or the piece count on the front of the pack.

  • 4 L
  • 9 L

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Howmedica Osteonics Corp. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Howmedica Osteonics Corp. — 325 Corporate Dr, Mahwah, NJ, 07430-2006

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Howmedica Osteonics Corp. medical devices recalled?

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 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 07613327504811, 07613327016789, 07613327016796. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls