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.
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