FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442030, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (VLP MINI-MOD) 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-0397-2018
- Recalling firm
- Smith & Nephew, Inc.
- Product
- smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442030, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (VLP MINI-MOD) 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
- 2017-12-11
- Posted
- not on file
- Terminated
- 2018-06-22
- Reason
- Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa
- Root cause
- Mixed-up of materials/components
- Action
- The firm, Smith & Nephew, Inc., sent an "Urgent Medical Device Recall Notice" letter dated December 11, 2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect your inventory, locate unused devices and quarantine immediately; if you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out; return product, and complete and return the response form by email to FieldActions@smith-nephew.com or fax to 901-566-7975 even if you have not product to return. If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com or call 901-566-7084.
- Quantity
- 2 units
- Distribution
- US Distribution to states of: MI, GA, and OH.
- Lot, serial or model codes
- Lot number 16KM10662C
- 510(k) numbers
- ["K132886"]
- 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