Smith & Nephew, Inc. recalls TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16

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.

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

• FDA enforcement recordOfficial FDA database entry for Z-2456-2026
• FDA 510(k) clearance · K210980The device's official FDA premarket clearance record
• FDA device classification · HSBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3020The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Smith & Nephew, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.