Rejuvenate Modular Stems Stryker Ireland Carrigtwohill recall
Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica…
Why was Rejuvenate Modular Stems Stryker Ireland Carrigtwohill recalled?
Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is 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 has decided to remove the affected product from the field since there may be an
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
510 K092561 all lots Rejuvenate (NLS/NLV) Rejuvenate (SPT) (4845-4XXX and NLS/NLV)
- Product
- Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica…
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- (NLS/NLV) - 23193 units and (SPT) - 20,743 units
- Distribution
- Nationwide Distribution
- Recall date
- August 1, 2012
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)