Recall Z-1133-2022 ยท JDS Nail, Fixation, Bone
Smith & Nephew Orthopaedics GmbH
INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
| Date | Apr 22, 2022 |
| Status | Open, Classified |
| Reason | Right nails were anodized, marked, and labelled as left nails and vice versa |
| Root cause | Under Investigation by firm |
| Action | The firm sent out a recall notification letter via email and overnight mail on 04/22/2022. The letter instructs the consignee to check inventory, return affected product, and complete the response form. Distributors were informed to notify their customers of the field action. |
| Quantity | 17 units |
| Distribution | Distributed nationwide to GA, OH, IN, TX, CO, MO, TN, CA, NC, PA and internationally to Canada, Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040212 | TRIGEN INTERTAN Smith & Nephew, Inc., Feb 20, 2004 |