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U.S. Department of Health and Human Services

Class 3 Device Recall VHS

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  Class 3 Device Recall VHS see related information
Date Initiated by Firm September 06, 2006
Date Posted November 15, 2006
Recall Status1 Terminated 3 on February 21, 2007
Recall Number Z-0181-2007
Recall Event ID 36377
510(K)Number K011603  
Product Classification hip screw system - Product Code KTT
Product VHS Pediatric Plate (for hip screw system)
Ref 200501, VHS Pediatric Plate Stainless Steel
Rx only, sterile
Code Information 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.
Recalling Firm/
Manufacturer		 EBI, L.P.
100 Interpace Pkwy
Parsippany NJ 07054-1149
For Additional Information Contact William Hennig
973-299-9300 Ext. 1557
Manufacturer Reason
for Recall		 VHS Plate and lag screw components did not assemble correctly intraoperatively.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KTT and Original Applicant = WALTER ABENDSCHEIN, M.D.
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