Recalls / —

—#159397

Product

smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL

FDA product code

JDS — Nail, Fixation, Bone

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K040212

Affected lot / code info

Lot number 16LM07111

Why it was recalled

A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.

Root cause (FDA determination)

Employee error

Action the firm took

Smith & Nephew sent an Urgent Medical Device Recall Notice dated October 24, 2017, to all affected customers. The firm requested return of the product. Please follow the instructions on the attached Response Form. For further questions, please call (978) 749-1440.

Recalling firm

Firm

Smith & Nephew, Inc.

Address

1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern

US Distribution - TN, IL, CT, MO, CA., and Internationally to Italy and Germany

Timeline

Recall initiated

2017-10-24

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #159397. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.