VHS Pediatric Hip Screw System Ped VHS, Lag Screw Ref # 200516 Stainless Steel, Rx only
FDA device recall Z-0180-2007 · posted 2006-11-15 · Terminated
Recall details
- Recalling firm
- EBI, L.P.
- Reason for recall
- VHS Plate and lag screw components did not assemble correctly intraoperatively.
- Action taken
- Recall notification was sent out by US mail on 9/6/2006 indicating the lot number(s) of product received.
- Root cause
- Other
- Status
- Terminated
- Product code
- KTT
- Quantity affected
- 1117 in distributor inventory, 205 implanted, 1372 in manufacturer's control
- Distribution
- Nationwide
- Date initiated
- 2006-09-06
- Date posted
- 2006-11-15
- Date terminated
- 2007-02-21
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VHS PEDIATRIC HIP SCREW SYSTEM (K011603) | Walter Abendschein, M.D. | 2001-08-15 |