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U.S. Department of Health and Human Services

Class 2 Device Recall INFUSE(R) Bone Graft

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 Class 2 Recall
INFUSE(R) Bone Graft
see related information
Date Posted June 25, 2013
Recall Status1 Terminated on May 13, 2014
Recall Number Z-1590-2013
Recall Event ID 65297
Premarket Approval
PMA Number
P000058
Product Classification Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction - Product Code NEK
Product INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
Code Information Lots: M111063AAA, M111063AAB, M111064AAI, M111064AAF, M111064AAE, 111064AAT, M111064AAU, M111064AAX, M111064AAJ, M111064AAR, M111064AAS
Recalling Firm/
Manufacturer
Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis, Tennessee 38132
For Additional Information Contact Eric Epperson
901-344-1435
Manufacturer Reason
for Recall
Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Medtronic on behalf of Integra LifeSciences Corporation sent an Urgent Voluntary Removal (Recall) letter on May 24, 2013, directly to all Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included. Foreign consignees were notified by email on May 28, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the product and discontinue use. The letter should be forwarded to surgeons or attending physicians who have used the affected products. Customers were instructed to use the attached questionnaire to account for product in their possession, document which physicians they notified and report any patient injuries that may have occurred related to the use of the affected product by calling the phone number in the questionnaire. Customers were asked to return the questionnaire using the enclosed self-addressed stamped envelope, via their Medtronic Sales Representative or via fax to 763-367-8134 For questions regarding this recall 901-399-3182. Customers were instructed to contact their Medtronic Sales Representative to coordinate the return and replenishment of affected product . Customers with questions should call 800-876-3133, ext 3197.
Quantity in Commerce 8884 units
Distribution Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.
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.
PMA Database PMAs with Product Code = NEK and Applicant = MEDTRONIC SOFAMOR DANEK USA, INC.
PMAs with Product Code = NEK and Applicant = MEDTRONIC SOFAMOR DANEK, INC.
PMAs with Product Code = NEK and Applicant = MEDTRONIC, INC.
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