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TRIGEN recallZ-2456-2026 · Smith & Nephew, Inc. · initiated Mar 16, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smith & Nephew, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

On 3/16/2026, recall notices were emailed to customers who were asked to do the following: 1) Locate and quarantine affected devices immediately. If you have further distributed the product to other organizations, please inform them at once of this Field Action and provide to them a copy of this letter. 3. Please complete the Customer Response form and email or fax it to your national Smith+Nephew agency/distributor. 4. Return quarantined product to your national Smith+Nephew agency/distributor. 5. Please maintain awareness of this notice and resulting action for an appropriate period to ensure the effectiveness of the corrective action. Firm contact information: + 1 901 396 2121, 1 800 821 5700

Recall details

Recall number
Z-2456-2026
Status
Open, Classified
Initiated by the company
Mar 16, 2026
Posted by the FDA
Jun 16, 2026
Recalling firm
Smith & Nephew, Inc.
Quantity
5
Product code
HSB
FDA submissions
K210980
Distribution
International distribution to the countries of BE, DE, IT.

Product description

TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816

Code information (models, lots, serial numbers)

UDI-DI: 03596010514394. Lot/Batch: 25BM03616

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

130 devices cleared under K210980 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page