Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011
FDA device recall Z-1557-2013 · posted 2013-06-19 · Terminated
Recall details
- Recalling firm
- Synthes USA HQ, Inc.
- Reason for recall
- The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. This action is not being initiated as a result of adverse events.
- Action taken
- The firm initiated their recall of the product on February 22, 2013 by sending an "Urgent Notice: Medical Device Recall" letter to the firm's sales representatives. The letter requested they examine their inventory, and/or customers inventories for the Part Number and if found, return it to Synthes for appropriate disposition.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 10
- Distribution
- Nationwide distribution.
- Date initiated
- 2013-02-22
- Date posted
- 2013-06-19
- Date terminated
- 2015-05-21
- 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 |
|---|---|---|
| SYNTHS ONE-THIRD TUBULAR DCL PLATE (K011335) | Synthes (Usa) | 2001-07-27 |