Cutting Edge Acetabular Spherical Reamer 44 M, Stryker Howmedica Osteonics Howmedica Osteonics Corp. 325 Corporate Drive

FDA device recall Z-1618-2012 · posted 2012-05-17 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

A 46mm acetabular reamer was lasermarked as a 44m reamer and distributed to the field.

Action taken

Stryker sent an "URGENT PRODUCT RECALL" letter dated December 29, 2011 to all affected customers. Notification letters and Product Accountability Forms were sent to Stryker accounts via FedEx on January 3, 2012 with return receipt. Hospital Risk Management and Chief of Orthopaedics Notification letters and Product Recall Acknowledgement Forms were sent on January 10, 2012. Surgeon Notification letters and Product Recall Acknowledgement Forms were sent on January 10, 2012. Notification sent via e-mail toCanada.EMEA, LatinAmerica.Asia Pacific on December 23, 2011. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to return the affected product. A Product Recall Acknowledgment Form was attached to the letter for customers to complete and return. Contact the firm at 201-972-2100 for questions regarding this recall.

Root cause

Device Design

Status

Terminated

Product code

HTO

Quantity affected

134 units

Distribution

Worldwide Distribution.

Date initiated

2011-12-23

Date posted

2012-05-17

Date terminated

2013-07-17

Location

Mahwah, NJ