Stryker Orthopaedics, Definition PM Femoral Hip Stem
Medical device recall Z-1982-2012. Published in FDA’s Enforcement Report on Jul 18, 2012.
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 Jul 18, 2012. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 16,913 units 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?
Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. The Definition PM femoral hip stem is a forged, collared, straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is integral to the design as it aligns, centralizes and pressurizes the stem within the femoral canal. The forged stem is first grit blasted proximally and then the premantle is applied through an infection molding process.
16,913 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Listed as Catalogue Number followed by Lot Number: 6265-3-099 8024501 6265-3-099 8024502 6265-3-099 11160601 6265-3-099 11650201 6265-3-099 11650202 6265-3-099 12915801 6265-3-099 12915802 6265-3-099 12915803 6265-3-099 12915804 6265-3-099…
Every code shown here, 2,000 characters
Listed as Catalogue Number followed by Lot Number: 6265-3-099 8024501 6265-3-099 8024502 6265-3-099 11160601 6265-3-099 11650201 6265-3-099 11650202 6265-3-099 12915801 6265-3-099 12915802 6265-3-099 12915803 6265-3-099 12915804 6265-3-099 12915805 6265-3-099 14027701 6265-3-099 14027702 6265-3-099 14503501 6265-3-099 14525001 6265-3-099 14525002 6265-3-099 14525003 6265-3-099 19943601 6265-3-099 19943602 6265-3-099 19943603 6265-3-099 19943604 6265-3-099 21500101 6265-3-099 21500102 6265-3-099 22108201 6265-3-099 22108202 6265-3-099 22260101 6265-3-099 23164201 6265-3-099 23731701 6265-3-099 23731801 6265-3-099 23731802 6265-3-099 23731803 6265-3-099 23843302 6265-3-099 23843303 6265-3-099 23843304 6265-3-099 23843305 6265-3-099 23843306 6265-3-099 23844101 6265-3-099 24321501 6265-3-099 24321502 6265-3-099 24321503 6265-3-099 24589701 6265-3-099 24589702 6265-3-099 24589703 6265-3-099 24589704 6265-3-099 25025901 6265-3-099 25025902 6265-3-099 25025903 6265-3-099 25025904 6265-3-099 27951601 6265-3-099 27951602 6265-3-099 27951603 6265-3-099 27951604 6265-3-099 27951605 6265-3-099 28008201 6265-3-100 18010702 6265-3-100 18363101 6265-3-100 18363102 6265-3-100 18363103 6265-3-100 18363104 6265-3-100 18981801 6265-3-100 19253701 6265-3-100 19253702 6265-3-100 19601801 6265-3-100 19602301 6265-3-100 19602302 6265-3-100 19898201 6265-3-100 19898202 6265-3-100 19898203 6265-3-100 19898204 6265-3-100 20507301 6265-3-100 20507302 6265-3-100 20542501 6265-3-100 20542502 6265-3-100 20953101 6265-3-100 22260201 6265-3-100 22260202 6265-3-100 22349901 6265-3-100 22349902 6265-3-100 22441501 6265-3-100 22441502 6265-3-100 22499401 6265-3-100 32573902 6265-3-100 34145101 6265-3-100 34145102 6265-3-100 34145103 6265-3-100 34145104 6265-3-100 34145105 6265-3-100 34145106 6265-3-100 34748701 6265-3-100 34748702 6265-3-100 34748901 6265-3-100 34748903 6265-3-100 34748904 6265-3-100 35484501 6265-3-100 35484502 6265-3-100 35484503 6265-3-100 35484504 6265-3-100 36275202 6265-3-100…
FDA’s list runs to 72,417 characters. The first part is shown; the rest is on FDA’s record.
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.
Nationwide Distribution
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Dec 29, 2011.
- FDA classified it on Jul 10, 2012.
- FDA’s Enforcement Report published it on Jul 18, 2012.
- FDA terminated it on Mar 19, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker 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.”
- FDA’s list of codes runs to 72,417 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.