—#69662

Product

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

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: All lot codes since 1998; Catalog Number 8000-3303

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: Products were distributed worldwide.

Timeline

Recall initiated: 2008-03-18
Posted by FDA: 2008-09-20
Terminated: 2010-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69662. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.