Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate s
FDA device recall Z-1174-2014 · posted 2014-03-11 · Terminated
Recall details
- Recalling firm
- Synthes, Inc.
- Reason for recall
- Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications.
- Action taken
- Synthes sent an Urgent Medical Medical Device Recall letter, dated January 27, 2013, to Users and Sales Consultants. The letter identified the affected product, reason for recall, potential hazard, and actions to be taken. Customers were instructed to complete the verification section. For questions call 610-719-5450 or contact your Synthes Sales Consultant. .
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 18747
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2014-01-27
- Date posted
- 2014-03-11
- Date terminated
- 2016-08-26
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE (K915818) | Synthes (Usa) | 1992-01-17 |