Scorpio Adjustable Femoral A/P Sizing Guide Assembly; non-sterile instruments; Howmedica Osteonics Corp., 325 Corporate

FDA device recall Z-0927-2011 · posted 2011-01-19 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

Stryker Orthopaedics has become aware that there is a potential for the shoulder screw on the Scorpio Sizing Guide (the "Sizing Guide") to disassociate from the main body of the instrument.

Action taken

Stryker Orthopaedics sent an 'Urgent Update Product Recall' letter dated December 30, 2010, along with Product Acknowledgement forms to all customers (US and international). The letter described the product, problem and action to be taken by the customers. The customers were asked to complete and return the PRODUCT RECALL ACKNOWLEDGMENT FORM within five (5) days via fax at 201-831-6069; contact the hospitals in their territory that have the affected product to arrange return of the product; and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100 or the Associate Product Manager, Knee Marketing Team, at (201) 831-5028.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

237 units

Distribution

Worldwide distribution: USA and countries including: Australia, Brazil, China, Columbia, France, Greece, India, Italy, Korea, Poland, Singapore, South Africa, and United Kingdom.

Date initiated

2010-09-27

Date posted

2011-01-19

Date terminated

2013-07-31

Location

Mahwah, NJ