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U.S. Department of Health and Human Services

Class 3 Device Recall OsteoStim Cervical Allograft

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 Class 3 Recall
OsteoStim Cervical Allograft
see related information
Date Posted February 14, 2008
Recall Status1 Terminated on April 15, 2008
Recall Number Z-0825-2008
Recall Event ID 45502
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
Product OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog Number : LGAL906, Distributed by EBI. (dba Biomet Spine, Biomet Trauma, Biomet Bracing, Biomet Osteobiologics) Parsippany, New Jersey 07054
Code Information Catalog Number 45-5537;-Lot Numbers; 9677005006, 9677004606, 9677004906, 9677005206, 9677005306, 9677004406, 9677004506, 9677005506, 9677004706,, 9677005106, 9677004806, A0640037, A0630038, 9677005406, 9677005606, 967700416, and 9677004206; Catalog number LGAL906-Lot Number: 9346003406
Recalling Firm/
Manufacturer
EBI, L.P.
100 Interpace Pkwy
Parsippany, New Jersey 07054-1149
Manufacturer Reason
for Recall
Unapproved Testing: Tissue supplier (LifeLink) utilized unapproved diagnostic testing on certain lots of distributed donor tissue instead of the FDA approved donor screening test. (Note: tissue samples were later re-tested by an approved method and found non-reactive)
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Urgent Recall Notice letters were mailed on October 23, 2007, requesting location of all product including sub-accounts and return for credit.
Quantity in Commerce 19 units
Distribution Nationwide to distributors/customers in NY, NC, MO, CA, FL and KS
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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