TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
FDA Recall Z-2456-2026 · Posted 2026-06-16
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Recalling FirmSmith & Nephew, Inc.
Recall StatusOpen, Classified
Product CodeHSB
Date Initiated2026-03-16
Product Quantity5
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.
Firm 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
Root Cause
Process control
Distribution Pattern
International distribution to the countries of BE, DE, IT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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