—#144953

Product

5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K041533
Affected lot / code info: Lot Number 5539094, Catalog ID # 02.221.462S Manufacture date 07/02/2007 Expiration date 05/31/2012

Why it was recalled

This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration date.

Root cause (FDA determination)

Process control

Action the firm took

DePuy Synthes mailed to customers an Urgent Notice informing them they were voluntarily recalling 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm-Sterile, part # 02.221.462S, Lot # 5539094, expiration date May 31, 2012, due to the units being shipped after the expiration date of May 31, 2012. Customers were instructed to call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, complete the Verification Section on page 3 by checking the appropriate box and return the form and product to Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: Distributed in IL and IN.

Timeline

Recall initiated: 2016-04-04
Terminated: 2016-09-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144953. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.