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RecallWatchMedical Device Safety
Class IIOngoingZ-3197-2026

Howmedica Osteonics Corp. recalls ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518…

Howmedica Osteonics Corp.Mahwah, NJ, United StatesReported Sep 23, 2026 · 6 days ago
Legal News Analyst ·

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

  • 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)
    UDI-DI 07613327025491
    111 affected lots
    MLKY8AMLL8E182-2-0512045465404006112332515182-2-05180454654040063523640051
    +103 more82-2-0912045465404007582686285182-3-0318045465403643192820855178-5-091007613327366006305824013058260173-27100761332703384714HDSA73-261007613327014082193307A193307E73-01100761332705028873-0710076133270502958P83DL4V73-09100761332705033214NACD3044-00260761332703377914SCVA14SCVD14SCVF72-4-9114076133270348758H39KP72-4-0324076133270343562350575172-16-0512076131540205151737665119093651231259512783595172-16-0518076131540205392562155172-16-0912076131540206521787945172-16-111207613154020737227648513052-111507613327034240MJ7YY6UH1-52-26076133270171685J8PM2UH1-58-26076133270173591R8TNH414A2L4W1HD7AV0J7JE226XAE50DAWM31665WK1WP2X90ML6UH1-48-2807613327017014N046DWN06WWPN20WDMN75AY1P419XWRP3D0XTD218RV15WA1VH06PAVN3P18VR853HWM8KJTXE2ND8YH0N93UH1-52-2807613327017182V02MMEUH1-55-2807613327017281R30MMEUH1-49-3207613327017069324H9HUH1-51-32076133270171209J6N9EUH1-52-32076133270172125D4NMJ9T612EUH1-54-3207613327017267

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 details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

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
Legal News Analyst

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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