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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 87-Orthopedic


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-2600741-2/2/1 22-Jun-2011 87HRS 3004968149 Rz Medizintech Gmbh Germany
 
W16-5024047-8/1/1 02-Jun-2011 87HRX 3001064361 Blatejewski Medi-Tech Germany
 
AW6-0223593-5/1/9 30-Jun-2011 87HWC 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/30 30-Jun-2011 87HXC 3002807827 Orthofix Srl Italy
 
BJV-0240244-5/75/9 02-Jun-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0240472-2/82/3 02-Jun-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0240472-2/82/5 02-Jun-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0240519-0/92/3 02-Jun-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0240519-0/92/6 02-Jun-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0240552-1/72/4 02-Jun-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0240582-8/76/1 08-Jun-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0240674-3/72/3 08-Jun-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0240668-5/87/3 08-Jun-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0240660-2/85/14 10-Jun-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0240660-2/85/6 10-Jun-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0240660-2/85/4 10-Jun-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0240660-2/85/20 10-Jun-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0240752-7/91/4 10-Jun-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0240212-2/76/3 13-Jun-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0240713-9/82/3 13-Jun-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0240954-9/87/3 17-Jun-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0240954-9/87/18 17-Jun-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0240954-9/87/13 17-Jun-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0240961-4/86/3 17-Jun-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0240963-0/83/2 17-Jun-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0240977-0/59/15 17-Jun-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0240979-6/64/5 20-Jun-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241041-4/77/4 21-Jun-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241041-4/77/12 21-Jun-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0241007-5/83/19 22-Jun-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241007-5/83/9 22-Jun-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241017-4/82/11 22-Jun-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241023-2/74/5 22-Jun-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
AW6-0223593-5/3/3 30-Jun-2011 87JDP 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/29 30-Jun-2011 87JDP 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/37 30-Jun-2011 87JDS 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/14 30-Jun-2011 87JDS 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/21 30-Jun-2011 87JDS 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/22 30-Jun-2011 87JDS 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/3/2 30-Jun-2011 87JDS 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/15 30-Jun-2011 87JDS 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/13 30-Jun-2011 87JDS 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/12 30-Jun-2011 87JDS 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/24 30-Jun-2011 87JDS 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/34 30-Jun-2011 87JDS 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/35 30-Jun-2011 87JDS 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/27 30-Jun-2011 87LYT 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/33 30-Jun-2011 87LYT 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/32 30-Jun-2011 87LYT 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/6 30-Jun-2011 87LYT 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/2 30-Jun-2011 87MRY 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/16 30-Jun-2011 87MRY 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/18 30-Jun-2011 87MRY 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/25 30-Jun-2011 87MRY 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/3/5 30-Jun-2011 87MRY 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/28 30-Jun-2011 87MRY 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/7 30-Jun-2011 87MRY 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/5 30-Jun-2011 87MRY 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/4 30-Jun-2011 87MRY 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/20 30-Jun-2011 87MRY 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/17 30-Jun-2011 87MRY 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/1 30-Jun-2011 87MRY 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/8 30-Jun-2011 87NDF 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/19 30-Jun-2011 87NDJ 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/3/6 30-Jun-2011 87NDJ 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/3/4 30-Jun-2011 87NDJ 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/3 30-Jun-2011 87NDJ 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/3/7 30-Jun-2011 87NDJ 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/23 30-Jun-2011 87NDJ 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/26 30-Jun-2011 87NDJ 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/31 30-Jun-2011 87NDJ 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/38 30-Jun-2011 87NDJ 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/3/1 30-Jun-2011 87NDJ 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/10 30-Jun-2011 87NDJ 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/36 30-Jun-2011 87NDJ 3002807827 Orthofix Srl Italy
 
AW6-0223593-5/1/11 30-Jun-2011 87NDJ 3002807827 Orthofix Srl Italy
 
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