Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm lengt

FDA device recall Z-0483-2014 · posted 2013-12-11 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

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.

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

HWC

Quantity affected

Catalog Number 2030-6525-1- 4 units; Catalog No: 2029-5540-1-7 units

Distribution

Nationwide Distribution

Date initiated

2013-10-01

Date posted

2013-12-11

Date terminated

2015-07-15

Location

Mahwah, NJ

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