Recall Z-0396-2018

Smith & Nephew, Inc. · initiated December 11, 2017

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442024, 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.

Codes / lots: Lot number 15GM08498C

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

FDA-determined cause: Mixed-up of materials/components

Action taken

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.

Details

Recall number
Z-0396-2018
Initiated
December 11, 2017
Terminated
June 22, 2018
Product code
HRS – Plate, Fixation, Bone
Quantity
2 units
Distribution
US Distribution to states of: MI, GA, and OH.
Recalling firm
Smith & Nephew, Inc., Memphis, TN

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0397-2018 Class IIsmith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System…Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM… 12/11/2017Terminated