FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc. Endoscopy Division: Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x 12 working length. Non-Sterile Catalog Number: 013554 Orthopedic Manual Surgical Instrument
- Recall number
- Z-3050-2011
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Product
- Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x 12 working length. Non-Sterile Catalog Number: 013554 Orthopedic Manual Surgical Instrument
- Status
- Terminated
- Initiated
- 2011-07-07
- Posted
- 2011-08-22
- Terminated
- 2015-07-23
- Reason
- Shaft tip (casting) does not meet the SNE 416 specification, which could result in rusting of the Tendon Strippers
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 570 units
- 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, serial or model codes
- Lot Numbers: 50342499, 50344799, 50347017, 50349339 50354170, 50357485, 50360691, 50360992 50367247, 50374544, 50375820, 50370949 50371944
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3003604053
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28