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Terminated

X-Celerate Universal Block Pegless Size #3, Non Sterile;

FDA Recall Z-1691-2008 · Posted 2008-09-20

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLXH
Date Initiated2008-03-18
Date Terminated2010-10-25
Product Quantity175 units in US, 453 units internationally

Reason for Recall

Discovery of the potential for Pin and Punch interference of the Size 3 Scorpio Notch Preparation Guide that may result in damage to bone if a user aggressively attempts to seat an obstructed punch.

Firm Action

Urgent Product Correction notification letters were sent via Federal Express, return receipt to all users on March 18, 2008. Questions should be directed to Rita Intorella, Divisional Regulatory Reporting at (201) 831-5825.

Root Cause

Device Design

Distribution Pattern

Products were distributed worldwide.

Official Source

View FDA Recall →

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

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