TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
FDA device recall Z-2456-2026 · posted 2026-06-16 · Open, Classified
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- HSB
- Quantity affected
- 5
- Distribution
- International distribution to the countries of BE, DE, IT.
- Date initiated
- 2026-03-16
- Date posted
- 2026-06-16
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Smith & Nephew Intramedullary Nail Systems (K210980) | Smith & Nephew, Inc. | 2022-11-14 |