Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall VHS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recall VHSsee related information
Date Initiated by FirmSeptember 06, 2006
Date PostedNovember 15, 2006
Recall Status1 Terminated 3 on February 21, 2007
Recall NumberZ-0181-2007
Recall Event ID 36377
510(K)NumberK011603 
Product Classification hip screw system - Product Code KTT
ProductVHS 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 ContactWilliam 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
ActionRecall notification was sent out by US mail on 9/6/2006 indicating the lot number(s) of product received.
Quantity in Commerce363 in distributor inventory, 205 implanted, 352 plates in manufacturer's control
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KTT
-
-