FDAFDA · Food and drugs·Recall number Z-2155-2012
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.
Published August 15, 2012 · Recall initiated: April 23, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Spine
- Distributor
- Worldwide Distribution -- US, Switzerland, Netherlands, Brazil, Hong Kong, Germany, and Taiwan.
- Lot
- Lot Code: 093309
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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