Z-0408-2018 Class II Terminated
FDA device recall Z-0408-2018 was initiated by Smith & Nephew, Inc. on November 29, 2017 and is designated Class II. Reason for recall: One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates. The recall status is terminated (terminated September 1, 2020). Affected quantity: 12.
Recall Details
- Product Type
- Devices
- Report Date
- January 31, 2018
- Initiation Date
- November 29, 2017
- Termination Date
- September 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12
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.
Distribution Pattern
US Distribution to the state of OR, and Internationally to Colombia.
Code Information
17AM14602