FDA Device recall Z-1982-2012
Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107
- FDA Device
- Class II
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class II recall of Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107 by Stryker Howmedica Osteonics, citing stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1982-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-12-29 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | US |
Product
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.
Reason
Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product.
Identifiers
| code_info | Listed as Catalogue Number followed by Lot Number: 6265-3-099 8024501 6265-3-099 8024502 6265-3-099 11160601 6265-3…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- |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1982-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.