Recalls / —

—#82453

Product

IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery.

FDA product code

LXH — Orthopedic Manual Surgical Instrument

Device class

Class 1

Medical specialty

Orthopedic

Affected lot / code info

Lot Number: 08K22270

Why it was recalled

Incorrect depth gauge mark etched onto guide wire pin. Guide pin is too long.

Root cause (FDA determination)

Process design

Action the firm took

Urgent Medical Device Recall letter dated January 23, 2009. All affected Smith & Nephew Sales Representatives, Distributors and Hospitals were notified of problem and the recall via Fed Ex and e-mail on 01/22/2009. They were instructed to immediately check their inventory and return the product.

Recalling firm

Firm

Smith & Nephew Inc

Address

1450 E. Brooks Rd, Memphis, Tennessee 38116

Distribution

Distribution pattern

Distribution to USA, Switzerland and Australia.

Timeline

Recall initiated

2009-01-22

Posted by FDA

2009-08-04

Terminated

2011-08-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #82453. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.