PlainRecalls
FDA Devices Moderate Class II 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.

Reported: January 31, 2018 Initiated: November 29, 2017 #Z-0408-2018

Product 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 for Recall

One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.

Details

Recalling Firm
Smith & Nephew, Inc.
Units Affected
12
Distribution
US Distribution to the state of OR, and Internationally to Colombia.
Location
Memphis, TN

Frequently Asked Questions

What product 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.. Recalled by Smith & Nephew, Inc.. Units affected: 12.
Why was this product recalled?
One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 31, 2018. Severity: Moderate. Recall number: Z-0408-2018.