CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report

Acetabular Cup Uhmwpe 61-3258 All Poly Constrained Insert recalled

Howmedica Osteonics is recalling Acetabular Cup Uhmwpe 61-3258 All Poly Constrained Insert 69-2244 All Poly Constrained, distributed nationwide in the US. The recall was initiated on 30 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes61-3258 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 recalled12,156 US

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3201-2026
FDA event ID: 99558
Recalling firm: Howmedica Osteonics, Mahwah, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 30 Jul 2026
FDA classified: 16 Sep 2026
Reported: 23 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

30 Jul 2026	Recall initiated by company
16 Sep 2026	Classified by FDA	+48 days
23 Sep 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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)

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

11 other products · FDA event 99558

This product is part of a recall event; the main page for the event is Scorpio C-dome Patella 73-2710 73-2910 Scorpio U-dome recalled.

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026	CLASS II	Scorpio C-dome Patella 73-2710 73-2910 Scorpio U-dome recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026	CLASS II	Abg I Acetabular Insert Hooded Id C-m079-2-801 Arc2f recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026	CLASS II	Omnifit Series I Acet recalled by Howmedica Osteonics	Howmedica Osteonics	Other	Nationwide
23 Sep 2026	CLASS II	Trident 0¿ Poly Insert ID 620-00-28D Orthopaedic implant recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026	CLASS II	All Poly Constrained Insert 69-2854 Nrg Knee Cr recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026	CLASS II	Duracon XL Angled Tib Ins C-m064-1-300 Self-pressurizing recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026	CLASS II	Scorpio + Mobile Bearing Pcs 78-5-0910 System One Bipolar recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026	CLASS II	Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026	CLASS II	Scorpio Recessed Metal Backed Patella 3045 recalled	Howmedica Osteonics	Foreign Material	Nationwide
23 Sep 2026	CLASS II	Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026	CLASS II	Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics	Howmedica Osteonics	Other	Nationwide

More recalls from Howmedica Osteonics

All 244

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Scorpio Recessed Metal Backed Patella 3045 recalled	Howmedica Osteonics	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Scorpio + Mobile Bearing Pcs 78-5-0910 System One Bipolar recalled	Howmedica Osteonics	Other	Nationwide

Other Hip & Knee Implants recalls

All 3,109

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Scorpio Recessed Metal Backed Patella 3045 recalled	Howmedica Osteonics	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Scorpio + Mobile Bearing Pcs 78-5-0910 System One Bipolar recalled	Howmedica Osteonics	Other	Nationwide