Lower riskMedical device recall · FDA · Published August 12, 2024
Smith & Nephew Rotation Medical Tendon Staples Recall: Packaging Seal Risk
Smith & Nephew recalls certain Rotation Medical Tendon Staples due to potential improper packaging seals that could compromise sterility. Affected units include specific batch numbers for prosthetic tissue fixation.
Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
“Smith & Nephew Rotation Medical Tendon Staples Recall: Packaging Seal Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54241-smith-nephew-rotation-medical-tendon-staples-recall-packaging-seal-risk. Based on FDA recall #Z-3097-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3097-2024%22&limit=1).
The FDA announced on Aug. 12, 2024, that Smith & Nephew Inc. is recalling ROTATION MEDICAL TENDON STAPLES (8) due to packaging defects that may compromise sterility. The recall affects 2,961 units distributed worldwide.
GovInfoNow's records show the product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch. This defect compromises the sterility of the ROTATION MEDICAL TENDON STAPLES.
Context
Smith & Nephew, Inc. has 66 other recalls on record since July 24, 2017. Other recent recalls of similar products include Smith & Nephew TRIGEN Humeral Nail Recall (March 16, 2026), Smith & Nephew BIOSURE HA Screw Recall (Nov. 24, 2025), and Smith & Nephew META-TAN Screw Kit Recall (March 18, 2025). Other recent recalls of similar products include Medline Quick-Strip Bandages Recall (Oct. 27, 2025) and Medline Curad Bandages Recall (Oct. 27, 2025).
How to tell if you have this one
Check for batch numbers: 51192136 through 51224282. The product is labeled as 'Rotation Medical Tendon Staples (8) - narrow indication for prosthetic material to soft tissues'.
Brand
Smith & Nephew
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Chile, China, France, Germany, Great Britain, Greece, Hong Kong, India, Italy, Japan, Lithuania, Malaysia, Malta, New Zealand, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovenia, South Africa, Spain, Switzerland, United Arab Emirates/Dubai (UAE).
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201; UDI-DI: 00885556733486 Batch Numbers: 51192136 51192143 51192144 51192145 51192146 51192148 51192150 51192151 51192152 51192153 51192154 51204480 51204481 51204484 51204485 51204486 51204487 51204488 51204489 51204491 51223193 51223241 51223242 51223243 51223249 51224282
2961 units (OUS)
Based on the official FDA remedy
What to do — step by step
Check Product Batch
Verify the batch number on the packaging to see if it matches the listed affected batches.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Chile, China, France, Germany, Great Britain, Greece, Hong Kong, India, Italy, Japan, Lithuania, Malaysia, Malta, New Zealand, Poland, Portugal, Puerto…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3097-2024 (August 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3097-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.