Smith&nephew recalled over sterility concerns
- Recall date
- November 29, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Smith & Nephew, Inc. recalls smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)0088…
- Recall number
- Z-0408-2018
- FDA classification
- Class II
- Brand / firm
- Smith & Nephew, Inc.
- Sold / distributed
- US Distribution to the state of OR, and Internationally to Colombia.
Why it was recalled
One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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