CLASS II Device recall · Reported 15 Aug 2012 · FDA Enforcement Report

Luxor Retractor Base recalled by Stryker Spine

Stryker Spine is recalling Luxor Retractor Base. The recall was initiated on 23 Apr 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: 093309

Quantity recalled30 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2155-2012
FDA event ID: 62648
Recalling firm: Stryker Spine, Allendale, NJ
Classification: Class II
Status: Terminated
Recall initiated: 23 Apr 2012
FDA classified: 7 Aug 2012
Reported: 15 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

23 Apr 2012	Recall initiated by company
7 Aug 2012	Classified by FDA	+106 days
15 Aug 2012	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution -- US, Switzerland, Netherlands, Brazil, Hong Kong, Germany, and Taiwan.

Questions about this recall

Is Luxor Retractor Base recalled?

Yes. Stryker Spine recalled Luxor Retractor Base on 23 Apr 2012. The recall is Class II and its status is Terminated. Recall number Z-2155-2012.

Why was it recalled?

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

Which lots are affected?

Lot Code: 093309

Where was it sold?

Worldwide Distribution -- US, Switzerland, Netherlands, Brazil, Hong Kong, Germany, and Taiwan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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