Howmedica Osteonics Corp. recalls ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 AL…
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
- 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)UDI-DI 07613327038538134 affected lots19172319186769-224407613327025446990V1WD56JV4D74X5EDX56K2
+126 more
E67D6NEP10WLKP14HNNN8NM2P36TXMP95L8XRE4EK0X82K0D69-2246076133270254538X6EL169-2248076133270254609J3DPHA41E7DAD39A3RP673W69-285007613327025477MLL1M3MLLXT1MLLY6H69-285207613327025484MLL0NM2099-2250076133270314301K5VVW2367AK3X0NJD4W4MPLLV80NE2099-225207613327031447NV561WPM326V2099-2256076133270314543H5RRKAA7JK02099-286107613327031591MLLVL66636-0-41913SFLA6299-N-3320761332713887019ECK6302-H-6320761332713897915NKT690-00-22D07613327025538123J5R194RN0274HMK3M77NN5J8P895L82T0986HVMA23P1XE923WWMLMEW8MLNPX0VX6813690-00-22E076133270255454100R95V78KA711K4KEY7HL9KP576WL620XWMD8JH9T61W43XA0L27690-00-28F07613327025552284X4X2K2DW1E47WVYMLL8JJMLLP6KMLLYT7YE6959690-00-28G076133270255836D82749N8EWW690-00-32I076133270255903A2P684A40TV620-00-28D07613327313581MET76R690-10-28K07613327024449MHNRM4MKRH1MMLAAV7690-10-22E0761332702428929385D906WENDJ7TP1EK4TK5LA22KAWL248YXV01J8690-10-22F07613327024357A6592HL7140YP103P0W745P8690-10-28G07613327024326MLL4Y7690-10-28H07613327024319MLKNT7MLL1YN690-10-28I07613327024364MLL8L9
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 detailsHide
Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3201-2026
- FDA 510(k) clearance · K261624The device's official FDA premarket clearance record
- FDA device classification · KWZOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.3310The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Howmedica Osteonics Corp.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
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 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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