—#183399

Product

EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K140814
Affected lot / code info: Part Numbers: 72424030, 72424010, 72424012, 72424016, 72424018, 72424020, 72424022, 72424024, 72434026, 72434028, 72434030, 72423014, 72423016, 72434065, 72434070, 72434075, 72412465, 72424032, 72424040, 72424055, 72424075, 72424080, 72423044. Batch/Lots: 14FM17199R, 14FM01226R, 14FM01227R, 14FM02610R, 14FM03418R, 14FM03420R, 14FM03422R, 14FM03424R, 14FM13578R, 14FM13580R, 14FM13581R, 14FM15166R, 14FM15167R, 14FM16225R, 14FM16228R, 14FM16229R, 14FM16386R, 14FM17201R, 14FM18527R, 14FM19218R, 14FM19226R, 14FM19229R, 14FM19360R.

Why it was recalled

Multiple or incorrect expiration dates were provided on the affected designation labels.

Root cause (FDA determination)

Error in labeling

Action the firm took

On August 24th the firm sent via email a notification to affected consignees. Consignees are asked to inspect inventory, locate and quarantine affected devices. Sales Reps and or distributors are instructed to notify customers of the field action and ensure required actions are complete. Affected product will be returned to Smith & Nephew. All consignees are asked to complete a Response Form, even if they do not have product to return.

Recalling firm

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

Distribution

Distribution pattern: International Distribution to the countries of Denmark, Sweden, France and Spain.

Timeline

Recall initiated: 2020-08-24
Terminated: 2022-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183399. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.