Z-3050-2011

Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x 12 working length. Non-Sterile Catalog Number: 013554...

Name: Z-3050-2011 Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x 12 working length. Non-Sterile Catalog Number: 013554...
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2011-07-07
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2011-07-07 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x 12 working length. Non-Sterile Catalog Number: 013554 Orthopedic Manual Surgical Instrument on 2011-07-07. The reason FDA records is "Shaft tip (casting) does not meet the SNE 416 specification, which could result in rusting of the Tendon Strippers". 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-3050-2011
Status: Terminated
Initiated: 2011-07-07
Posted: 2011-08-22
Terminated: 2015-07-23
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x 12 working length. Non-Sterile Catalog Number: 013554 Orthopedic Manual Surgical Instrument
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Shaft tip (casting) does not meet the SNE 416 specification, which could result in rusting of the Tendon Strippers
Root cause tag: manufacturing process
FDA 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 [email protected] 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, [email protected]. For questions, contact Hoangthi by phone at 508-337-3731.
Quantity in commerce: 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
Product codes and lots: Lot Numbers: 50342499, 50344799, 50347017, 50349339 50354170, 50357485, 50360691, 50360992 50367247, 50374544, 50375820, 50370949 50371944

Product code LXH

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)