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

FDA device recall Z-1691-2008 · posted 2008-09-20 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

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.

Action taken

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

Status

Terminated

Product code

LXH

Quantity affected

175 units in US, 453 units internationally

Distribution

Products were distributed worldwide.

Date initiated

2008-03-18

Date posted

2008-09-20

Date terminated

2010-10-25

Location

Mahwah, NJ