FDA Class II · Medical device · Recall Z-3201-2026 · Recalled September 23, 2026
ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINE recall — Howmedica Osteonics Corp. Compare identifiers Agency action Open official record ↗ Agency report date: September 23, 2026.
Source checks: October 22, 2026 at 6:00 PM UTC (oldest successful check).
Sources, dates and coverage limits We collect recent notices on a six-hour schedule using a rolling 90-day source request. Older retained records may also appear. This is a recall index, not a catalogue of all products or a complete recall history.
FDA: stored recall dates April 29, 2026 to October 14, 2026. USDA FSIS is not aggregated here. Check USDA meat, poultry and processed egg notices . EPA and U.S. Coast Guard are not aggregated. Source delays and missing identifiers can prevent a match.
1. Compare your item This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINE Company / brand Howmedica Osteonics Lot / serial / date codes 61-3258 UDI-DI 07613327038538 Lots 191723 191867 69-2244 UDI-DI 07613327025446 Lots 990V1W D56JV4 D74X5E DX56K2 E67D6N EP10WL KP14HN NN8NM2 P36TXM P95L8X RE4EK0 X82K0D 69-2246 UDI-DI 07613327025453 Lots 8X6EL1 69-2248 UDI-DI 07613327025460 Lots 9J3DPH A41E7D AD39A3 RP673W 69-2850 UDI-DI 07613327025477 Lots MLL1M3 MLLXT1 MLLY6H 69-2852 UDI-DI 07613327025484 Lots MLL0NM MLLAHY 2099-2250 UDI-DI 07613327031430 Lots 1K5VVW 2367AK 3X0NJD 4W4MPL LV80NE 2099-2252 UDI-DI 07613327031447 Lots NV561W PM326V 2099-2256 UDI-DI 07613327031454 Lots 3H5RRK AA7JK0 2099-2861 UDI-DI 07613327031591 Lot MLLVL6 6636-0-419 No UDI Lot 13SFLA 6299-N-332 UDI-DI 07613327138870 Lot 19ECK 6302-H-632 UDI-DI 07613327138979 Lot 15NKT 690-00-22D UDI-DI 07613327025538 Lots 123J5R 194RN0 274HMK 3M77NN 5J8P89 5L82T0 986HVM A23P1X E923WW MLMEW8 MLMTVP MLNPX0 VX6813 690-00-22E UDI-DI 07613327025545 Lots 4100R9 5V78KA 711K4K EY7HL9 KP576W L620XW MD8JH9 T61W43 XA0L27 690-00-28F UDI-DI 07613327025552 Lots 284X4X 2K2DW1 E47WVY MLL8JJ MLLKAY MLLP6K MLLYT7 YE6959 690-00-28G UDI-DI 07613327025583 Lots 6D8274 9N8EWW 690-00-32I UDI-DI 07613327025590 Lots 3A2P68 4A40TV 620-00-28D UDI-DI 07613327313581 Lot MET76R 690-10-28K UDI-DI 07613327024449 Lots MHNRM4 MKRH1M MLAAV7 690-10-22E UDI-DI 07613327024289 Lots 29385D 906WEN DJ7TP1 EK4TK5 LA22KA WL248Y XV01J8 690-10-22F UDI-DI 07613327024357 Lots A6592H L7140Y P103P0 W745P8 690-10-28G UDI-DI 07613327024326 Lot MLL4Y7 690-10-28H UDI-DI 07613327024319 Lots MLKNT7 MLL1YN MLLYXD 690-10-28I UDI-DI 07613327024364 Lots MLL8L9 MLLXWY Distribution Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa. Agency product description and boundaries 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 CONSTRAINED INSERT 28F 690-00-28F TRIDENT 0 DEG CONSTRAINED INSERT 28G 690-00-28G TRIDENT 0 DEG CONSTRAINED INSERT 32I 690-00-32I TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D TRIDENT CONSTR ACET INSERT 690-10-28K TRIDENT CONSTRAINED INSERT 690-10-22E 690-10-22F 690-10-28G 690-10-28H 690-10-28I Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action FDA reports: 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.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class II: may cause temporary or medically reversible health consequences.
Affected product: ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINE recall status
3. Open the official notice or contact View the official FDA enforcement record (openFDA) ↗
Official recall ID Z-3201-2026 Brand All Howmedica Osteonics recalls Classification Class II Units affected 12,156 US Recall status Ongoing Initiated Voluntary: Firm initiated Affected products Companies & origin Recalling firm location Mahwah, NJ, United States Firm address 325 Corporate Dr, N/A, 07430-2006 Identifying details (verbatim from the notice) Product codes / lots 61-3258 UDI-DI 07613327038538 Lots 191723 191867 69-2244 UDI-DI 07613327025446 Lots 990V1W D56JV4 D74X5E DX56K2 E67D6N EP10WL KP14HN NN8NM2 P36TXM P95L8X RE4EK0 X82K0D 69-2246 UDI-DI 07613327025453 Lots 8X6EL1 69-2248 UDI-DI 07613327025460 Lots 9J3DPH A41E7D AD39A3 RP673W 69-2850 UDI-DI 07613327025477 Lots MLL1M3 MLLXT1 MLLY6H 69-2852 UDI-DI 07613327025484 Lots MLL0NM MLLAHY 2099-2250 UDI-DI 07613327031430 Lots 1K5VVW 2367AK 3X0NJD 4W4MPL LV80NE 2099-2252 UDI-DI 07613327031447 Lots NV561W PM326V 2099-2256 UDI-DI 07613327031454 Lots 3H5RRK AA7JK0 2099-2861 UDI-DI 07613327031591 Lot MLLVL6 6636-0-419 No UDI Lot 13SFLA 6299-N-332 UDI-DI 07613327138870 Lot 19ECK 6302-H-632 UDI-DI 07613327138979 Lot 15NKT 690-00-22D UDI-DI 07613327025538 Lots 123J5R 194RN0 274HMK 3M77NN 5J8P89 5L82T0 986HVM A23P1X E923WW MLMEW8 MLMTVP MLNPX0 VX6813 690-00-22E UDI-DI 07613327025545 Lots 4100R9 5V78KA 711K4K EY7HL9 KP576W L620XW MD8JH9 T61W43 XA0L27 690-00-28F UDI-DI 07613327025552 Lots 284X4X 2K2DW1 E47WVY MLL8JJ MLLKAY MLLP6K MLLYT7 YE6959 690-00-28G UDI-DI 07613327025583 Lots 6D8274 9N8EWW 690-00-32I UDI-DI 07613327025590 Lots 3A2P68 4A40TV 620-00-28D UDI-DI 07613327313581 Lot MET76R 690-10-28K UDI-DI 07613327024449 Lots MHNRM4 MKRH1M MLAAV7 690-10-22E UDI-DI 07613327024289 Lots 29385D 906WEN DJ7TP1 EK4TK5 LA22KA WL248Y XV01J8 690-10-22F UDI-DI 07613327024357 Lots A6592H L7140Y P103P0 W745P8 690-10-28G UDI-DI 07613327024326 Lot MLL4Y7 690-10-28H UDI-DI 07613327024319 Lots MLKNT7 MLL1YN MLLYXD 690-10-28I UDI-DI 07613327024364 Lots MLL8L9 MLLXWY Distribution Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa. Firm notified the public via Letter FDA event ID 99558 Recall initiated July 30, 2026 FDA classified September 16, 2026 FDA report date September 23, 2026 Other medical device recalls from around the same time INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recall — CooperSurgical, Inc. FDA · September 30, 2026 INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP recall — CooperSurgical, Inc. FDA · September 30, 2026 Haylard UNIV IMAGING BIOPSY TRUCUSTOM recall — AVID Medical, Inc. FDA · September 23, 2026 Haylard BASIC BIOPSY TRAY recall — AVID Medical, Inc. FDA · September 23, 2026 Haylard CONTINUOUS NERVE BLOCK TRAY recall — AVID Medical, Inc. FDA · September 23, 2026
Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes;
the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.
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