—#95122

Product

Scorpio Fixed Femoral A/P Sizing Guide; non-sterile instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corporation The A/P sizer is designed to set the desired external rotation and to provide adjustment of the anterior/posterior position when needed.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number 8001-0313 Lot # RD3N198 & Lot #RD3N200

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

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

Timeline

Recall initiated: 2010-09-27
Posted by FDA: 2011-01-19
Terminated: 2013-07-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95122. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.