—#90658

Product

X-Celerate Instrumentation Punch Thru Tibial Base Plate, Catalog numbers: 3750-0003. 3750-0004, 3750-0005, 3740-0006, 3750-0007, 3750-0009, 3750-0011, 3750-0013; Stryker Howmedica Osteonics Corp Scorpio Total Knee System

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog numbers: 3750-0003. 3750-0004, 3750-0005, 3740-0006, 3750-0007, 3750-0009, 3750-0011, 3750-0013; All lots.

Why it was recalled

The locating pins on the Punch Thru Tibial Baseplates could break or disassociate from the main body of the instrument.

Root cause (FDA determination)

Device Design

Action the firm took

Stryker Urgent Device Correction letters dated April 5, 2010, were sent to all Stryker branches/agencies, hospital Risk Management and surgeons who have used the product by Federal Express. Questions on the bulletin should be directed to Scott Solis, Product Manager ,Knee Marketing at 201-831-5665.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA, China, Taiwan, India, Australia, Korea, Singapore, Germany, France, Spain, Italy, Switzerland, Poland, Romania, South Africa, United Kingdom, Netherlands, Sweden, Turkey, Japan, Chile, Brazil, Colombia, Mexico, Panama, Argentina, and Uruguay.

Timeline

Recall initiated: 2010-04-05
Posted by FDA: 2010-08-02
Terminated: 2012-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90658. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.