FDA Recall
Terminated
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.
Recall: Z-0408-2018
·
Initiated November 29, 2017
Recall
- Recall Number
- Z-0408-2018
- Event Number
- 78672
- Firm
- Smith & Nephew, Inc.
- FEI Number
- 1020279
- Product Code
- HRS
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- November 29, 2017
- Terminated
- September 1, 2020
- Address
- 1450 E Brooks Rd, Memphis, TN, 38116-1804
Description
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.
Reason
One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.
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.
Distribution
US Distribution to the state of OR, and Internationally to Colombia.
Quantity
12