Recall Z-0097-2018 ยท JDS Nail, Fixation, Bone
Smith & Nephew, Inc.
smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
| Date | Oct 24, 2017 |
| Status | Open, Classified |
| Reason | A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down. |
| Root cause | Employee error |
| Action | Smith & Nephew sent an Urgent Medical Device Recall Notice dated October 24, 2017, to all affected customers. The firm requested return of the product. Please follow the instructions on the attached Response Form. For further questions, please call (978) 749-1440. |
| Quantity | 17 units |
| Distribution | US Distribution - TN, IL, CT, MO, CA., and Internationally to Italy and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040212 | TRIGEN INTERTAN Smith & Nephew, Inc., Feb 20, 2004 |