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