LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Di

FDA device recall Z-2155-2012 · posted 2012-08-07 · Terminated

Recall details

Recalling firm

Stryker Spine

Reason for recall

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

GAD

Quantity affected

30 devices

Distribution

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

Date initiated

2012-04-23

Date posted

2012-08-07

Date terminated

2013-11-13

Location

Allendale, NJ