ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM
Summary
The FDA issued a Class II for ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 by Howmedica Osteonics Corp.. Reason: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the p.
Details
Source
Device Recall
External ID
Z-3201-2026
Action Date
2026-09-23
Status
Ongoing
Category
device
Product Description
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)
Lot/Code Info: 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
Quantity Affected: 12,156 US
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-30
Company
Mahwah, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Howmedica Osteonics Corp. has 124 FDA actions in our database, including 124 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Howmedica Osteonics Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Howmedica Osteonics Corp. have FDA actions?
Howmedica Osteonics Corp. has 124 FDA actions in our database, including 124 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3201-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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