FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: 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.
- Recall number
- Z-0408-2018
- Recalling firm
- Smith & Nephew, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2017-11-29
- Posted
- not on file
- Terminated
- 2020-09-01
- Reason
- One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.
- Root cause
- Employee error
- Action
- 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.
- Quantity
- 12
- Distribution
- US Distribution to the state of OR, and Internationally to Colombia.
- Lot, serial or model codes
- 17AM14602
- 510(k) numbers
- ["K140814"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28