Key facts
| Recalling firm | Smith & Nephew, Inc. |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816 |
| Classification | Class II |
| Recall number | Z-2456-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | 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. |
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816 -- and the recall number Z-2456-2026. If it matches, stop using or distributing it and contact Smith & Nephew, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Smith & Nephew, Inc. and the affected product is described in FDA's record as: TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816. FDA's stated reason for the recall is: 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 (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-2456-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
Smith & Nephew, Inc.’s FDA history
Argus HQ has recorded 1 total FDA action tied to Smith & Nephew, Inc.: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- How serious is this recall?
- FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
- What should someone who has this product do?
- Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816) and recall number Z-2456-2026, then follow Smith & Nephew, Inc.'s recall instructions.
- Has Smith & Nephew, Inc. had other FDA recalls or enforcement actions?
- This is the only FDA action Argus HQ has on file for Smith & Nephew, Inc. so far. Argus ingests new FDA enforcement records daily.
- What is the FDA recall number for this event?
- FDA recall number Z-2456-2026.
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Related enforcement actions
Full FDA history for Smith & Nephew, Inc.Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Class II Recall: TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16,… by Smith & Nephew, Inc. — Recall Details. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/fda-recall-smith-and-nephew-inc-z-2456-2026
"FDA Class II Recall: TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16,… by Smith & Nephew, Inc. — Recall Details." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/fda-recall-smith-and-nephew-inc-z-2456-2026.
Argus HQ Research. "FDA Class II Recall: TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16,… by Smith & Nephew, Inc. — Recall Details." Digital Empire Holdings LLC. Accessed August 13, 2026. https://argushq.ai/recall/fda-recall-smith-and-nephew-inc-z-2456-2026.
@misc{argushq_argushq_ai_recall_fda_recall_smith_and_nephew_inc_z_2456_2026_2026,
title = {FDA Class II Recall: TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16,… by Smith & Nephew, Inc. — Recall Details},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/recall/fda-recall-smith-and-nephew-inc-z-2456-2026},
note = {Accessed: August 13, 2026}
}Source: FDA.gov — Recalls ↗