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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker LUXOR RETRACTOR

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  Class 2 Device Recall Stryker LUXOR RETRACTOR see related information
Date Initiated by Firm April 23, 2012
Date Posted August 07, 2012
Recall Status1 Terminated 3 on November 13, 2013
Recall Number Z-2155-2012
Recall Event ID 62648
Product Classification Retractor - Product Code GAD
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.
Code Information Lot Code: 093309
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Ms. Michelle Barry
201-760-8287
Manufacturer Reason
for Recall		 Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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