FDA Recall
Terminated
VHS Pediatric Hip Screw System Ped VHS, Lag Screw Ref # 200516 Stainless Steel, Rx only
Recall: Z-0180-2007
·
Initiated September 6, 2006
Recall
- Recall Number
- Z-0180-2007
- Event Number
- 36377
- FEI Number
- 2242816
- Product Code
- KTT
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 6, 2006
- Posted
- November 15, 2006
- Terminated
- February 21, 2007
- Address
- EBI, L.P. 100 Interpace Pkwy, Parsippany, NJ, 07054-1149
Description
VHS Pediatric Hip Screw System Ped VHS, Lag Screw Ref # 200516 Stainless Steel, Rx only
Reason
VHS Plate and lag screw components did not assemble correctly intraoperatively.
Action
Recall notification was sent out by US mail on 9/6/2006 indicating the lot number(s) of product received.
Distribution
Nationwide
Quantity
1117 in distributor inventory, 205 implanted, 1372 in manufacturer's control