Recall Z-1132-2013 ยท HSB Rod, Fixation, Intramedullary And Accessories
Smith & Nephew Inc
TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery
| Date | Apr 17, 2013 (initiated Mar 6, 2013) |
| Status | Terminated |
| Reason | One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter). |
| Root cause | Process control |
| Action | Smith & Nephew sent an Urgent Product Recall Notification letter dated March 6, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease use and distribution of the affected product and quarantine for return. Non-responding consignees were notified again on March 15, 2013, by email. Surgeons were to be notified by letter beginning on March 20, 2013. For questions regarding this recall call 978-749-1330. |
| Quantity | 23 units |
| Distribution | Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111025 | TRIGEN LOW PROFILE BONE SCREW Smith & Nephew, Inc., Jul 1, 2011 |