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…
Medical device recall Z-3197-2026. Published in FDA’s Enforcement Report on Sep 23, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 23, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 12,156 US how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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)
12,156 US, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,445 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 30, 2026.
- FDA classified it on Sep 16, 2026.
- FDA’s Enforcement Report published it on Sep 23, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Howmedica Osteonics Corp., of Mahwah, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.