FDA Recall Terminated

Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical

Recall: Z-0801-2011 · Initiated November 5, 2010

Recall

Recall Number
Z-0801-2011
Event Number
57210
FEI Number
1000116912
Product Code
KWS
Status
Terminated
Root Cause
Device Design
Initiated
November 5, 2010
Posted
December 22, 2010
Terminated
April 5, 2011
Address
9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

Description

Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical

Reason

Complaints of fracturing were reported for affected trial products.

Action

Encore Medical notified consignees by letter on 11/5/2010.

Distribution

TX, FL, SC, GA

Quantity

34 units