Stryker Definition PM Femoral Hip Stem Recalled for PMMA Coating Cracking
Stryker Howmedica Osteonics is recalling 16,913 Definition PM Femoral Hip Stems due to potential cracking of the PMMA coating. The devices were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a structural component (PMMA coating) of an implanted medical device. While no injuries are reported, the potential for cracking in a load-bearing implant represents a significant risk of harm, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 16,913 units of the Definition PM Femoral Hip Stem, catalog numbers 6265-3-099 through 6265-3-107. The recall is due to the potential for cracking of the Poly Methyl Methacrylate (PMMA) coating on the device. The PMMA premantle is an integral part of the design intended to align, centralize, and pressurize the stem within the femoral canal.
The affected devices were manufactured in Ireland and distributed nationwide. The recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Patients who have had this specific hip stem implanted should contact their orthopedic surgeon to discuss the potential risk and determine if further evaluation or intervention is necessary. The recall notice does not provide specific consumer instructions beyond the identification of the affected catalog and lot numbers.
The recalled product
- 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, Ced
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 16,913
Distribution
Distributed nationwide across the United States.
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