Class 2 Device Recall TRIGEN

• Date Initiated by Firm: March 16, 2026
• Date Posted: June 16, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2456-2026
• Recall Event ID: 98629
• 510(K)Number: K210980
• Product Classification: Rod, fixation, intramedullary and accessories - Product Code HSB
• Product: TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
• Code Information: UDI-DI: 03596010514394. Lot/Batch: 25BM03616
• FEI Number: 1020279
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 1450 E Brooks Rd; Memphis TN 38116-1804
• For Additional Information Contact: 901-396-2121
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: 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
• Quantity in Commerce: 5
• Distribution: International distribution to the countries of BE, DE, IT.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HSB