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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 VHSsee related information
Date Initiated by FirmSeptember 06, 2006
Date PostedNovember 15, 2006
Recall Status1 Terminated 3 on February 21, 2007
Recall NumberZ-0180-2007
Recall Event ID 36377
510(K)NumberK011603 
Product Classification hip screw system - Product Code KTT
ProductVHS Pediatric Hip Screw System Ped VHS, Lag Screw Ref # 200516 Stainless Steel, Rx only
Code Information 200511 Intermediate VHS Lag Screw 35MM. Lot #s 089397, 224149, 227018,228282, 276052,284944,299271,321772,326236, 572150,576380. 200512 Intermediate VHS Lag Screw 40 MM, Lot #s115120, 172137,257775,271524,297135,299272,572160,576400. 200513 Intermediate VHS Lag Screw 45 MM, Lot #s 089398,197199,210829,243847,284087,297136,307909, 309419, 749310. 200514 Intermediate VHS Lag Screw 50 MM, Lot #s 115130,174095,224464,276169,276053,284088,299273, 326237, 749340. 200515 Intermediate VHS Lag Screw 55MM, Lot #s 089399,178703,224167,275771, 297137,321775,326238,333721,572180, 576410. 200516 Intermediate VHS Lag Screw 60 MM, Lot #s 089400,227860,275775,277702,287521,299274,301001, 344610, 749350. 200517 Intermediate VHS Lag Screw 65 MM, Lot #s 089401,224293,275778,284945,297138,299275,321776, 749370. 200518 Intermediate VHS Lag Screw 70 MM, Lot #s 089402,243848,275780,287522,297139,304127,749380. 200519 Intermediate VHS Lag Screw 75 MM, Lot #s 089403,267170,267172,299276,321777,352316,353922, 366390,749390,. 200520 Intermediate VHS Lag Screw 80 MM, Lot #s 104564,  168448, 285930,321778, 329174..299277,299278,302214,321784,366400, 747410. 200521 Intermediate VHS Lag Screw 85 MM, Lot #s 089404, 267171, 275783,299277,299278,302214,321784,366400, 747410. 200522 Intermediate VHS Lag Screw 90 MM, Lot #s 168449,  284947,321782,329175,357520. 200523 Intermediate VHS Lag Screw 95MM, Lot #s 104567,168294,217920,344219,345861,347823.361016, 749420. 200524 Intermediate VHS Lag Screw 100MM, Lot #s 104570, 168450,181749,302216,312049,321786,342630,749430.
FEI Number 2242816
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 Commerce1117 in distributor inventory, 205 implanted, 1372 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
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