PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 15, 2012 Initiated: April 23, 2012 #Z-2155-2012

Product Description

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.

Reason for Recall

Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu.

Details

Recalling Firm
Stryker Spine
Units Affected
30 devices
Distribution
Worldwide Distribution -- US, Switzerland, Netherlands, Brazil, Hong Kong, Germany, and Taiwan.
Location
Allendale, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Stryker Spine. Units affected: 30 devices.
Why was this product recalled?
Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 15, 2012. Severity: Moderate. Recall number: Z-2155-2012.