DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray case that contains t
FDA device recall Z-0349-2007 · posted 2007-01-19 · Terminated
Recall details
- Recalling firm
- OrthoHelix Surgical Designs Inc
- Reason for recall
- The 48 distal locking-screws (ranging from 10-24mm) contained in the kit are not within established specifications, specifically the minor diameter of the screws are undersized.
- Action taken
- The recalling firm contacted all consignees by phone on or about 8/3/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 180
- Distribution
- The product was distributed to 5 consignees located in the U.S.: Archway Medical, Columbia, SC; Gulf Coast Surgical, Stafford, TX; Vaugham Medical, Wheat Ridge, CO; Belemy Medical, Cleveland, OH; and
- Date initiated
- 2006-08-03
- Date posted
- 2007-01-19
- Date terminated
- 2012-09-10
- Location
- Akron, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DRLOCK DISTAL RADIUS VOLAR SYSTEM (K053182) | Orthohelix Surgical Designs, Inc. | 2006-02-27 |