Device 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.
Z-2155-2012
Product summary
- Firm
- Stryker Spine
- Event
- Event 62648
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 devices
- Official record key
device-enforcement:Z-2155-2012
Official wording
Reason: Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu.
Code information: Lot Code: 093309
Distribution pattern: Worldwide Distribution -- US, Switzerland, Netherlands, Brazil, Hong Kong, Germany, and Taiwan.
Derived failure modes
-
Unknown
Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu.