Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0180-2007

VHS Pediatric Hip Screw System Ped VHS, Lag Screw Ref # 200516 Stainless Steel, Rx only

Ebi, LLC / initiated 2006-09-06 / Terminated

EBI, L.P. began a recall of VHS Pediatric Hip Screw System Ped VHS, Lag Screw Ref # 200516 Stainless Steel, Rx only 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-0180-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Ebi, LLC
Product
VHS Pediatric Hip Screw System Ped VHS, Lag Screw Ref # 200516 Stainless Steel, Rx only
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
1117 in distributor inventory, 205 implanted, 1372 in manufacturer's control
Distribution
Nationwide
Product codes and lots
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.