Stryker Recalls Rejuvenate Modular Hip Stems and Necks
Stryker is recalling Rejuvenate Modular Hip System stems and necks due to a reported rate of less than one percent for revisions associated with fretting or corrosion.
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 involves a medical device with a reported rate of revisions (implant failures) due to mechanical issues (fretting/corrosion). While the rate is low (<1%), the potential for harm from implant failure in a medical device places this in the 'High' category (risk-of-harm products where injury has not yet been reported as a widespread epidemic, but specific failures are documented). It is not Class I (Critical) as no deaths or serious injuries are explicitly reported in the text, nor is it Class III (Low) as it involves a functional defect leading to revision.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling Rejuvenate Modular Stems and Rejuvenate Modular Necks. The recall involves 23,193 units of NLS/NLV stems and 20,743 units of SPT stems. The product was distributed nationwide.
The recall is a product correction based on a reported rate of less than one percent for revisions potentially associated with fretting and/or corrosion at or about the modular neck junction. On June 29, 2012, Stryker decided to remove the affected product from the field.
This recall affects patients who have received these specific hip implants. The source text does not provide specific instructions for consumers or patients on how to proceed, but the product is being removed from the field.
The recalled product
- Product
- Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The M
- Manufacturer
- Stryker Howmedica Osteonics Corp.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Stryker Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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