Recall Z-0181-2007

Ebi, L.P. · initiated September 6, 2006

Terminated

Product

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

Codes / 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.

Reason for recall

VHS Plate and lag screw components did not assemble correctly intraoperatively.

FDA-determined cause: Other

Action taken

Recall notification was sent out by US mail on 9/6/2006 indicating the lot number(s) of product received.

Details

Recall number
Z-0181-2007
Initiated
September 6, 2006
Posted by FDA
November 15, 2006
Terminated
February 21, 2007
Product code
KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Quantity
363 in distributor inventory, 205 implanted, 352 plates in manufacturer's control
Distribution
Nationwide
Recalling firm
Ebi, L.P., Parsippany, NJ

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0180-2007 VHS Pediatric Hip Screw System Ped VHS, Lag Screw Ref # 200516 Stainless Steel, Rx onlyVHS Plate and lag screw components did not assemble correctly intraoperatively. 09/06/2006Terminated