Nail Holding Screw; 1 unit per package Stryker Trauma GmbH; Distributed by Howmedica Osteonics Corp., 325 Corporate Driv

FDA device recall Z-0331-2011 · posted 2010-11-09 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

Variations in the outer diameter of the shaft of the External Compression Device and the inner diameter of the Nail Holding Screw may make assembly of these 2 instruments not possible.

Action taken

Stryker sent Recall notification letters by Federal Express on September 9, 2010 to all Stryker branches/agencies and Risk Managers, Chief of Orthopaedics of affected hospitals and Surgeons on September 10, 2010, that used the product. The letter identified the product, the problem, and the action that customers should take. Customers were instructed to: Examine their inventory and hospital locations to identify the affected product and return it to their branch or agency warehouse for reconciliation. Reconcile all product on the attached Product Recall Acknowledgment Form and fax a copy to (201) 831-6069 within 5 days of receipt of notice. A Stryker representative would contact the customer with details for return of the product. For any questions regarding this recall call (201) 972-2100.

Root cause

Other

Status

Terminated

Product code

HSB

Quantity affected

22

Distribution

Nationwide Distribution including AZ, CA, CO, FL, GA, IL, KY, MD, OH, OK, and TX

Date initiated

2010-08-30

Date posted

2010-11-09

Date terminated

2012-08-21

Location

Mahwah, NJ