UnratedMedical device recall · FDA · Published June 24, 2020
Smith & Nephew TRIGEN Nail Recall: Manufacturing Error in Sterilization Process
Smith & Nephew recalls TRIGEN intramedullary nails with a manufacturing error causing improper re-sterilization of the UHMWPE sleeve. Affected models include 71655139 lot 19BM13592A.
“Smith & Nephew TRIGEN Nail Recall: Manufacturing Error in Sterilization Process.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64912-smith-nephew-trigen-nail-recall-manufacturing-error-in-sterilization-process. Based on FDA recall #Z-2685-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2685-2020%22&limit=1).
Smith & Nephew, Inc. voluntarily recalled its TRIGEN Intramedullary nail due to a manufacturing error involving re-sterilization of the UHMWPE sleeve, according to the FDA on June 24, 2020.
How to tell if you have it
Brand: Smith & Nephew
Product: TRIGEN, Intramedullary nail
Model: 71655139
Lot: 19BM13592A
Quantity: 12 units
The hazard
The recall cites a manufacturing error that resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
Context
GovInfoNow's records show Smith & Nephew, Inc. has had 66 other recalls on record since July 24, 2017. Other recent recalls of similar products include the Smith & Nephew TRIGEN Humeral Nail Recall (March 16, 2026), the Smith & Nephew BIOSURE HA Screw Recall (November 24, 2025), and the Smith & Nephew META-TAN Screw Kit Recall (March 18, 2025). Other recent recalls of similar products include the Medline Nail Kit Recall (January 5, 2026), the Charlotte Claw Screw Recall (August 18, 2026), and the Medline Surgical Drapes Recall (January 7, 2026).
How to tell if you have this one
Check for the model number 71655139 and lot number 19BM13592A on the TRIGEN intramedullary nail packaging or label. This recall applies to specific surgical implants used in orthopedic procedures.
Brand
Smith & Nephew
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the model number 71655139 and lot number 19BM13592A on the TRIGEN intramedullary nail.
How this recall unfolded
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-2685-2020 (June 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2685-2020 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.