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.
This recall has been terminated (originally issued November 29, 2017).
- Company
- Smith & Nephew Inc
- Recall Initiated
- November 29, 2017
- Terminated
- September 1, 2020
- Recall Number
- Z-0408-2018
- Quantity
- 12
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.
Distribution
US Distribution to the state of OR, and Internationally to Colombia.
Lot / Code Info
17AM14602
Root Cause
Employee error
Action Taken
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.
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