—#160615

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.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K132886
Affected lot / code info: Lot number 16KM10662C

Why it was recalled

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 (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

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

Timeline

Recall initiated: 2017-12-11
Terminated: 2018-06-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160615. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.