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Recall Observatory FDA recall evidence

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

April 23, 2012

Class II

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

    reason.no_named_rule · v1.0.0

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