DRL System Trays comprised of DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four Plate Styles include: Part Numb
FDA device recall Z-0136-2008 · posted 2007-12-19 · Terminated
Recall details
- Recalling firm
- OrthoHelix Surgical Designs Inc
- Reason for recall
- Seat/Fit problems: The heads of the distal screws/pegs rest above the surface of the distal plate after the screws/pegs are fully tightened.
- Action taken
- On 9/4/2007, OrthoHelix mailed an Important Recall Notification letters via certified mail to all direct accounts. The notification instructed all accounts to examine their inventory and return all recalled product, identified within the notification, to OrthoHelix for replacement.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 267 plates/52 DRL System Trays
- Distribution
- Nationwide; including states of IL, CA, VA, TX, MD, UT, GA, CO, NJ, OH, & WI.
- Date initiated
- 2007-09-04
- Date posted
- 2007-12-19
- Date terminated
- 2011-05-20
- 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 |