Use caution Medical device recall · FDA · Published March 16, 2026

Smith & Nephew TRIGEN Humeral Nail Recall: Missing Holes Risk Revision Surgery

Smith & Nephew recalls TRIGEN Proximal Straight Humeral Nail 8/7 X 16 with missing distal holes that may require revision surgery. Affected units have specific lot numbers and UDI-DI codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2456-2026Medical device Smith & Nephew ›

Use caution until it’s fixed

Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.

Take action

Contact the company

Recalling firmSmith & Nephew, Inc.1450 E Brooks Rd · Memphis, TN 38116-1804

✎ GovInfoNow plain-language explainer

Smith & Nephew is recalling a specific type of humeral nail due to a manufacturing error that causes missing distal holes. If implanted without checking, this could lead to revision surgery. However, identifying the missing holes before implantation allows for a backup solution. Read more at govinfonow.com/recall/49726-smith-nephew-trigen-humeral-nail-recall-missing-holes-risk-revision.

Source Summary by GovInfoNow · govinfonow.com/recall/49726-smith-nephew-trigen-humeral-nail-recall-missing-holes-risk-revision · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2456-2026

Cite this page

“Smith & Nephew TRIGEN Humeral Nail Recall: Missing Holes Risk Revision Surgery.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49726-smith-nephew-trigen-humeral-nail-recall-missing-holes-risk-revision. Based on FDA recall #Z-2456-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2456-2026%22&limit=1).

Smith & Nephew, Inc. recalled the TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16 due to a manufacturing error that may require revision surgery if implanted, according to the FDA on March 16, 2026.

How to tell if you have it

Brand: Smith & Nephew
Product: TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16
REF: 71760816
UDI-DI: 03596010514394
Lot/Batch: 25BM03616

The hazard

The humeral nail is missing distal holes due to a manufacturing error. If implanted, this defect may lead to revision surgery. If identified before implantation, an equivalent backup or a bent nail of the same size can be used, though the latter requires additional surgical steps that could delay surgery by more than 30 minutes.

Context

GovInfoNow's records show Smith & Nephew, Inc. has 66 other recalls on record since July 24, 2017. Recent brand recalls include a Nov. 24, 2025 BIOSURE HA Screw Recall for labeling error risk and a March 18, 2025 META-TAN Screw Kit Recall for non-functional screws. Other recent recalls of similar products include a Jan. 15, 2026 Encore Medical RSP Humeral Socket Insert Recall for incorrect labeling hazard.

How to tell if you have this one

Check for the product name 'TRIGEN Proximal Straight Humeral Nail 8/7 X 16' with UDI-DI code 03596010514394 and lot number 25BM03616. This specific model was sold with these identifiers.

Brand
Smith & Nephew
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Missing Holes
Inspect the nail for missing distal holes before implantation to determine if a backup solution is needed.

How this recall unfolded

Recall timeline

FDA published this recall 3 months after the firm started it.

Mar 16, 2026Firm started the recall
Jun 16, 2026FDA classified it Class II
Jun 24, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/49726-smith-nephew-trigen-humeral-nail-recall-missing-holes-risk-revision">Smith &amp; Nephew TRIGEN Humeral Nail Recall: Missing Holes Risk Revision Surgery (GovInfoNow)</a>

Where this comes from

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-2456-2026 (March 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2456-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.