Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical
This recall has been terminated (originally issued December 22, 2010).
- Recall Initiated
- November 5, 2010
- Posted
- December 22, 2010
- Terminated
- April 5, 2011
- Recall Number
- Z-0801-2011
- Quantity
- 34 units
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Complaints of fracturing were reported for affected trial products.
Distribution
TX, FL, SC, GA
Lot / Code Info
Part number 804-25-024, and 804-25-025
Root Cause
Device Design
Action Taken
Encore Medical notified consignees by letter on 11/5/2010.