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Terminated

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 Recall Z-2119-2010 · Posted 2010-08-02

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLXH
Date Initiated2010-04-05
Date Terminated2012-08-28
Product Quantity8276

Reason for Recall

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

Firm Action

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.

Root Cause

Device Design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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