Recall Z-0408-2018 ยท HRS Plate, Fixation, Bone
Smith & Nephew, Inc.
smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.
| Date | Nov 29, 2017 |
| Status | Terminated |
| Reason | One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates. |
| Root cause | Employee error |
| Action | Smith & Nephew Inc. initiated its recall by email on November 29, 2017. The consignee was directed to return the recalled product. For further questions, please call (901) 396-2121. |
| Quantity | 12 |
| Distribution | US Distribution to the state of OR, and Internationally to Colombia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140814 | EVOS MINI-FRAGMENT PLATING SYSTEM Smith & Nephew, Inc., May 7, 2014 |