Z-2155-2012Class II

LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I...

Name: Z-2155-2012 LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I...
Creator: Stryker Spine
Published: 2012-04-23
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2012-04-23 / Terminated / root cause: manufacturing process

FDA source

Stryker Spine began a recall of LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine... on 2012-04-23. FDA classified it as Class II and gives the reason as "Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2155-2012
Classification: Class II
Status: Terminated
Initiated: 2012-04-23
Posted: 2012-08-07
Terminated: 2013-11-13
Recalling firm: Howmedica Osteonics Corp
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.
Product code: GAD Retractor
Reason for recall: Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Stryker sent Urgent Product Recall letters/return response forms dated April 23, 2012 via FedEx to Stryker branches/agencies and hospitals where product might have been distributed. The letter identified the affected product, discussed the issue, potential hazards, risk mitigations, and the return process. Customers are to examine their inventory and reconcile any of the affected product with the information provided. In addition, the Customer Response Form should be completed and faxed back to Regulatory Compliance at 201-760-8370 within 5 days of receipt of the letter. The affected product should also be returned following the instructions provided. Questions should be directed to Dan Roberts, Regulatory Affairs Compliance Specialist at 201-760-8298.
Quantity in commerce: 30 devices
Distribution: Worldwide Distribution -- US, Switzerland, Netherlands, Brazil, Hong Kong, Germany, and Taiwan.
Product codes and lots: Lot Code: 093309

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2155-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2155-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-07

Product code GAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)