Recall Z-2456-2026 ยท HSB Rod, Fixation, Intramedullary And Accessories
Smith & Nephew, Inc.
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
| Date | Jun 16, 2026 (initiated Mar 16, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 ensur |
| Quantity | 5 |
| Distribution | International distribution to the countries of BE, DE, IT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210980 | Smith & Nephew Intramedullary Nail Systems Smith & Nephew, Inc., Nov 14, 2022 |