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

All Poly Constrained Insert 69-2854 Nrg Knee Cr recalled

Howmedica Osteonics is recalling All Poly Constrained Insert 69-2854 Nrg Knee Cr 82-2-0512 82-2-0518 82-2-0912 Nrg Knee, 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 codes69-2854 UDI-DI 07613327025491 Lots MLKY8A MLL8E1 82-2-0512 UDI-DI 04546540400611 Lot 23325151 82-2-0518 UDI-DI 04546540400635 Lot 23640051 82-2-0912 UDI-DI 04546540400758 Lot 26862851 82-3-0318 UDI-DI 04546540364319 Lot 28208551 78-5-0910 UDI-DI 07613327366006 Lots 30582401 30582601 73-2710 UDI-DI 07613327033847 Lot 14HDSA 73-2610 UDI-DI 07613327014082 Lots 193307A 193307E 73-0110 UDI-DI 07613327050288 Lot HHPW 73-0710 UDI-DI 07613327050295 Lots 8P83 DL4V 73-0910 UDI-DI 07613327050332 Lot 14NACD 3044-0026 UDI-DI 07613327033779 Lots 14SCVA 14SCVD 14SCVF 72-4-9114 UDI-DI 07613327034875 Lot 8H39KP 72-4-0324 UDI-DI 07613327034356 Lot 23505751 72-16-0512 UDI-DI 07613154020515 Lots 17376651 19093651 23125951 27835951 72-16-0518 UDI-DI 07613154020539 Lot 25621551 72-16-0912 UDI-DI 07613154020652 Lot 17879451 72-16-1112 UDI-DI 07613154020737 Lot 22764851 3052-1115 UDI-DI 07613327034240 Lot MJ7YY6 UH1-52-26 UDI-DI 07613327017168 Lot 5J8PM2 UH1-58-26 UDI-DI 07613327017359 Lots 1R8TNH 414A2L 4W1HD7 AV0J7J E226XA E50DAW M31665 WK1WP2 X90ML6 UH1-48-28 UDI-DI 07613327017014 Lots N046DW N06WWP N20WDM N75AY1 P419XW RP3D0X TD218R V15WA1 VH06PA VN3P18 VR853H WM8KJT XE2ND8 YH0N93 UH1-52-28 UDI-DI 07613327017182 Lot V02MME UH1-55-28 UDI-DI 07613327017281 Lot R30MME UH1-49-32 UDI-DI 07613327017069 Lot 324H9H UH1-51-32 UDI-DI 07613327017120 Lot 9J6N9E UH1-52-32 UDI-DI 07613327017212 Lots 5D4NMJ 9T612E UH1-54-32 UDI-DI 07613327017267 Lot MNNAAL

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-3197-2026
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

ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SCORPIO INSET PATELLA 73-2610 SCORPIO M-DOME PATELLA 73-0110 73-0710 73-0910 SCORPIO RECESSED PATELLA 26MM 3044-0026 SCORPIO TS TIB INS 72-4-9114 SCORPIO TS TIBIAL INSERT 72-4-0324 SCORPIOFLEX TOTAL KNEE CR 72-16-0512 72-16-0518 72-16-0912 72-16-1112 SERIES II TIBIAL BEAR INSERT NO 11 15MM 3052-1115 UHR BIPOLAR 26X52mm UH1-52-26 UHR BIPOLAR 26X58mm UH1-58-26 UHR BIPOLAR 28X48mm UH1-48-28 UHR BIPOLAR 28X52mm UH1-52-28 UHR BIPOLAR 28X55mm UH1-55-28 UHR BIPOLAR 32X49MM UH1-49-32 UHR BIPOLAR 32X51MM UH1-51-32 UHR BIPOLAR 32X52MM UH1-52-32 UHR BIPOLAR 32X54MM UH1-54-32 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?

69-2854 UDI-DI 07613327025491 Lots MLKY8A MLL8E1 82-2-0512 UDI-DI 04546540400611 Lot 23325151 82-2-0518 UDI-DI 04546540400635 Lot 23640051 82-2-0912 UDI-DI 04546540400758 Lot 26862851 82-3-0318 UDI-DI 04546540364319 Lot 28208551 78-5-0910 UDI-DI 07613327366006 Lots 30582401 30582601 73-2710 UDI-DI 07613327033847 Lot 14HDSA 73-2610 UDI-DI 07613327014082 Lots 193307A 193307E 73-0110 UDI-DI 07613327050288 Lot HHPW 73-0710 UDI-DI 07613327050295 Lots 8P83 DL4V 73-0910 UDI-DI 07613327050332 Lot 14NACD 3044-0026 UDI-DI 07613327033779 Lots 14SCVA 14SCVD 14SCVF 72-4-9114 UDI-DI 07613327034875 Lot 8H39KP 72-4-0324 UDI-DI 07613327034356 Lot 23505751 72-16-0512 UDI-DI 07613154020515 Lots 17376651 19093651 23125951 27835951 72-16-0518 UDI-DI 07613154020539 Lot 25621551 72-16-0912 UDI-DI 07613154020652 Lot 17879451 72-16-1112 UDI-DI 07613154020737 Lot 22764851 3052-1115 UDI-DI 07613327034240 Lot MJ7YY6 UH1-52-26 UDI-DI 07613327017168 Lot 5J8PM2 UH1-58-26 UDI-DI 07613327017359 Lots 1R8TNH 414A2L 4W1HD7 AV0J7J E226XA E50DAW M31665 WK1WP2 X90ML6 UH1-48-28 UDI-DI 07613327017014 Lots N046DW N06WWP N20WDM N75AY1 P419XW RP3D0X TD218R V15WA1 VH06PA VN3P18 VR853H WM8KJT XE2ND8 YH0N93 UH1-52-28 UDI-DI 07613327017182 Lot V02MME UH1-55-28 UDI-DI 07613327017281 Lot R30MME UH1-49-32 UDI-DI 07613327017069 Lot 324H9H UH1-51-32 UDI-DI 07613327017120 Lot 9J6N9E UH1-52-32 UDI-DI 07613327017212 Lots 5D4NMJ 9T612E UH1-54-32 UDI-DI 07613327017267 Lot MNNAAL

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	Acetabular Cup Uhmwpe 61-3258 All Poly Constrained Insert 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	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