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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 Device Recall INFUSE(R) Bone Graft see related information
Date Initiated by Firm May 28, 2013
Date Posted June 25, 2013
Recall Status1 Terminated 3 on May 13, 2014
Recall Number Z-1589-2013
Recall Event ID 65297
PMA Number P000058 
Product Classification Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteo - Product Code NEK
Product INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132

Code Information Lots: M111057AAP, M111064AAD, M111064AAC, M111063AAJ, M111064AAK, M111064AAL, M111064AAV, M111064AAM, M111064AAW, M111064AAG, M111057AAM, M111063AAD, M111064AAQ, M111064AAO, M111064AAP, M111063AAP, M111064AAB, M111063AAC, M111064AAY, M111057AAD, M111057AAE
Recalling Firm/
Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis TN 38132
For Additional Information Contact Eric Epperson
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
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 22936 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NEK and Original Applicant = Medtronic Sofamor Danek USA, Inc.