Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0181-2007

VHS Pediatric Plate (for hip screw system) Ref 200501, VHS Pediatric Plate Stainless Steel Rx only, sterile

Ebi, LLC / initiated 2006-09-06 / Terminated

EBI, L.P. began a recall of VHS Pediatric Plate (for hip screw system) Ref 200501, VHS Pediatric Plate Stainless Steel Rx only, sterile on . The reason FDA records is "VHS Plate and lag screw components did not assemble correctly intraoperatively". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0181-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Ebi, LLC
Product
VHS Pediatric Plate (for hip screw system) Ref 200501, VHS Pediatric Plate Stainless Steel Rx only, sterile
Product code
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall
VHS Plate and lag screw components did not assemble correctly intraoperatively.
FDA root cause
Other
Action
Recall notification was sent out by US mail on 9/6/2006 indicating the lot number(s) of product received.
Quantity in commerce
363 in distributor inventory, 205 implanted, 352 plates in manufacturer's control
Distribution
Nationwide
Product codes and lots
200501 Intermediate VHS Plate Keyless 3 holes, Lot #s 074550, 186055, 210448, 212643, 257687, 272019, 296837, 299392, 344607,355441, 586500, 591030, 881240. 200502 Intermediate VHS Plate Keyless 4 holes, Lot #s 118980, 187153, 190506,2 24463, 227017, 271523, 287520, 299267, 344608, 586510, 591050. 200503 Intermediate VHS Plate Keyless 6 holes, Lot #s 178300, 223594, 246879, 257773, 297133, 299268, 326234, 366450, 749300. 200504 Intermediate VHS Plate Keyless 8 holes, Lot #s 112505, 257774, 299269, 326235, 344609. 200505 Intermediate VHS Plate Keyless 10 holes, Lot #s 112506, 149310, 299270.