Device Recall Stryker Orthopaedics 의 리콜

Recall

66908

Class 2

Z-0483-2014

2013-10-01

2013-12-11

Terminated

United States

2015-07-15

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124144

Stryker received a report from the field indicating that a 5.5 mm cancellous bone screw 40 mm was identified in packaging associated with a 6.5 mm cancellous bone screw 25 mm.

Stryker sent notification letters/accountability forms via Fed Ex on October 1, 2013, with return receipt. to branches/agencies and hospital risk management, chief of orthopedics and surgeons. Domestic branch locations were notified by e-mail on 9/16/2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fax the Product Recall Acknowledgement Form to 855-251-3635, return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, 07430. Customers were instructed to attach the fluorescent organge PRODUCT REMEDIATION sticker to their return, indicating the Produc Remediation # RA 2013-145. Mark the outer box with the words "Product Recall." Customers with questions were instructed to call 201-972-2100. For questions regarding this recall call 201-831-5000.