Turon Shoulder System Instrumentation, Turon Humeral Head Trials, 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-0798-2011
- Quantity
- 425 units
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Complaints of fracturing were reported for trial products.
Distribution
TX, FL, SC, GA
Lot / Code Info
Part numbers: 804-05-021, 804-05-022, 804-05-023, 804-05-024, 804-05-025, 804-05-026, 804-05-027, 804-05-028, 804-05-029, 804-05-030, 804-05-031, 804-05-032, 804-05-033, 804-05-034, 804-05-035, 804-05-036, 804-05-037, 804-05-038, 804-05-039, 804-05-040, 804-05-041, 804-05-042, 804-05-043, 804-05-044, 804-05-045
Root Cause
Device Design
Action Taken
Encore Medical notified consignees by letter on 11/5/2010.