Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical
FDA device recall Z-0801-2011 · posted 2010-12-22 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Complaints of fracturing were reported for affected trial products.
- Action taken
- Encore Medical notified consignees by letter on 11/5/2010.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWS
- Quantity affected
- 34 units
- Distribution
- TX, FL, SC, GA
- Date initiated
- 2010-11-05
- Date posted
- 2010-12-22
- Date terminated
- 2011-04-05
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38 (K080402) | Encore Medical L.P. | 2008-03-28 |