FDA recall Z-0408-2018

Product

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 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.

Key facts

Status

Terminated

Initiation date

2017-11-29

Report date

2018-01-31

Termination date

2020-09-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0408-2018