Smith & Nephew, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0397-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 11, 2017

Date Posted: January 31, 2018

Recall Number: Z-0397-2018

Event ID: 78826

Reason for Recall:

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

Status: Terminated

Product Quantity: 2 units

Code Information:

Lot number 16KM10662C

Distribution Pattern:

US Distribution to states of: MI, GA, and OH.

Voluntary or Mandated:

Voluntary: Firm initiated