Recall Z-1637-2014 ยท JDS Nail, Fixation, Bone
Smith & Nephew Inc
TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc. Orthopedic fixation device.
| Date | May 20, 2014 (initiated Apr 4, 2014) |
| Status | Terminated |
| Reason | A manufacturing error resulted in the set screw being inserted too deep in the affected nails. |
| Root cause | Process control |
| Action | The firm initiated the recall via an "Urgent - Product Recall 1st Notification - Urgent" letter and e-mail on 04/04/2014, identifying the product, explaining the problem, and the potential risk associated with using the product. Customers are to inspect their inventory, and locate and quarantine any affected product. Additionally, the Inventory Return Certification form should be completed and returned along with any affected product identified, once a Return Authorization number has been obtained from Smith & Nephew's Safety Affairs Department. |
| Quantity | 1,253 units total |
| Distribution | Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040212 | TRIGEN INTERTAN Smith & Nephew, Inc., Feb 20, 2004 |