5.0 mm Periprosthetic Locking Screw Selftapping 12 mm Sterile 의 리콜

Recall

73770

Class 2

Z-1574-2016

2016-04-04

Terminated

United States

2016-09-02

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144953

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.

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.