Recall Z-2258-2014 ยท JDS Nail, Fixation, Bone
Smith & Nephew, Inc.
TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71675202, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 13MM X 18 CM NAIL, 125o, REF 71675203, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 10MM
| Date | Aug 17, 2014 (initiated Jul 2, 2014) |
| Status | Terminated |
| Reason | There was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R); INTERTAN(TM); NAILS. |
| Root cause | Under Investigation by firm |
| Action | Smith & Nephew Issued an Urgent Product Recall dated July 2, 2014 to all affected customers via E-mail and/or FedEx . The notification identified the effective product, problem and actions to be taken. Customers were instructed to: Inspect inventory and locate any unused affected devices, cease distribution and use of those products, quarantine them immediately, complete the last two columns in the Inventory Return Certification Form, and return any affected product to the address provided. For questions call 901-396-2121 |
| Quantity | 601 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of AUSTRALIA, CANADA, CHINA, INDIA, UAE, JAPAN, SOUTH AFRICA, SOUTH KOREA, UNITED KINGDOM. AUSTRIA, NORWAY, POLAND, PORTUGAL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040212 | TRIGEN INTERTAN Smith & Nephew, Inc., Feb 20, 2004 |