Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x 12 working length. Non-Sterile Catalog Number: 013554 Orthopedic Manual Surgical Instrument
This recall has been terminated (originally issued August 22, 2011).
- Recall Initiated
- July 7, 2011
- Posted
- August 22, 2011
- Terminated
- July 23, 2015
- Recall Number
- Z-3050-2011
- Quantity
- 570 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Shaft tip (casting) does not meet the SNE 416 specification, which could result in rusting of the Tendon Strippers
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark, Dubai, Finland, France, Germany, Greece, Hong Kong, India, Italy, Israel, Japan, Korea, Malaysia, Mexico, Netherland, Norway, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom, and Venezuela
Lot / Code Info
Lot Numbers: 50342499, 50344799, 50347017, 50349339 50354170, 50357485, 50360691, 50360992 50367247, 50374544, 50375820, 50370949 50371944
Root Cause
Nonconforming Material/Component
Action Taken
Smith & Nephew sent an Urgent - Product Recall Notification letter dated July 7, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the form included in the letter and return to Hoangthi.le@smith-nephew.com or fax to 508-261-3620. Each affiliate must then notify each facility affected by the recall. To return product and obtain credit or order replacement product customers should contact the Smith & Nephew Endoscopy Returns at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to, endo.andreturns@smith-nephew.com. For questions, contact Hoangthi by phone at 508-337-3731.