Recall Z-2155-2012
Stryker Spine · initiated April 23, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine. 2 Pearl Ct. Allendale, NJ 07401. Provides access to the thoracic and lumbar spine from a posterior approach via a small incision.
Codes / lots: Lot Code: 093309
Reason for recall
Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu.
FDA-determined cause: Nonconforming Material/Component
Action taken
Stryker sent Urgent Product Recall letters/return response forms dated April 23, 2012 via FedEx to Stryker branches/agencies and hospitals where product might have been distributed. The letter identified the affected product, discussed the issue, potential hazards, risk mitigations, and the return process. Customers are to examine their inventory and reconcile any of the affected product with the information provided. In addition, the Customer Response Form should be completed and faxed back to Regulatory Compliance at 201-760-8370 within 5 days of receipt of the letter. The affected product should also be returned following the instructions provided. Questions should be directed to Dan Roberts, Regulatory Affairs Compliance Specialist at 201-760-8298.
Details
- Recall number
- Z-2155-2012
- Initiated
- April 23, 2012
- Posted by FDA
- August 7, 2012
- Terminated
- November 13, 2013
- Product code
- GAD – Retractor
- Quantity
- 30 devices
- Distribution
- Worldwide Distribution -- US, Switzerland, Netherlands, Brazil, Hong Kong, Germany, and Taiwan.
- Recalling firm
- Stryker Spine, Allendale, NJ