Recalls / —

—#191373

Product

INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND

FDA product code

HRS — Plate, Fixation, Bone

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K073375

Affected lot / code info

UDI: (01)10381780052234 (11)21101 (10)FVRG, Batch Numbers: FTL9, FTLA, and FVRG

Why it was recalled

The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw

Root cause (FDA determination)

Process control

Action the firm took

The firm initiated the recall by letter and email on 01/04/2022. The letter requested that the consignee examine their inventory, quarantine all affected units, and return the completed response form. Entities who have further distributed the product were directed to notify their customers. The firm is seeking return of the product.

Recalling firm

Firm

Smith & Nephew, Inc.

Address

1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern

US Nationwide distribution in the states of CA and OH.

Timeline

Recall initiated

2022-01-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #191373. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.