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U.S. Department of Health and Human Services

Class 2 Device Recall InterGro DBM Demineralized Bone Matrix

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 Class 2 Recall
InterGro DBM Demineralized Bone Matrix
see related information
Date Posted September 17, 2008
Recall Status1 Terminated on October 21, 2008
Recall Number Z-2351-2008
Recall Event ID 48189
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
Product InterGro DBM Demineralized Bone Matrix in a lipid carrier; Provided by: Lifelink Tissue Bank, Tampa, Florida, EBI A Biomet Company, Parsippany, New Jersey; REF DBM002. InterGro DBM product contain human tissue (allograft bpm) and are intended for transplantation. Products are to be used for filling bony voids or gaps in the extremities, and pelvis that are not intrinsic to the bony stability of the structure.
Code Information Lots 259990 and 318630 (exp 07/2009).
Recalling Firm/
Manufacturer
Michigan Orthopaedic Products, Inc.
2905 Wilson Ave Sw Ste 100
Grandville, Michigan 49418-1287
For Additional Information Contact William S. Arim
616-249-8937
Manufacturer Reason
for Recall
Exposure to temperature extremes -- Product was not stored under controlled conditions and may have been temperature abused. Exposure to temperature extremes could cause problems with device safety (e.g. risk of infection) or problems with device effectiveness (e.g. lower healing rates if the factors or collagen in the device were affected by the temperature extremes).
FDA Determined
Cause 2
TRAINING: Employee Error
Action Three units were picked up from the consignee on or about 5/05/08. The implanting physician was verbally advised of the problem with the fourth unit. If you have any questions contact Michigan Orthopaedic Products, Inc. at (616) 249-8937.
Quantity in Commerce 4 packages
Distribution Class II Recall - Nationwide Distribution --- including the state of Michigan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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