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U.S. Department of Health and Human Services

Class 2 Device Recall Accell Evo3c Demineralized Bone Matrix Putty

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  Class 2 Device Recall Accell Evo3c Demineralized Bone Matrix Putty see related information
Date Initiated by Firm May 19, 2014
Date Posted June 25, 2014
Recall Status1 Terminated 3 on September 05, 2014
Recall Number Z-1868-2014
Recall Event ID 68330
510(K)Number K091193  
Product Classification Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
Product Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160.

Product Usage:
Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.
Code Information Model Number: 02-6000-050 , Lot Number: 132160.
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Mr. David E. Gronostajski
609-275-0500
Manufacturer Reason
for Recall		 This lot of Accell Evo3C Demineralized Bone Matrix, 5cc was incorrectly packaged in boxes that describe the product as Accell Evo3 Demineralized Bone Matrix. Evo3C is contraindicated for treatment of vertebral compression and not indicated for use in the posterolateral spine.
FDA Determined
Cause 2		 Packaging
Action Integra sent an Urgent Voluntary Medical Device Recall dated May 19, 2014 to customers via mail (traceable courier service). The recall notification letter identified affected product, reason for recall and actions to be taken Customers were instructed to complete the "RECALL ACKNOWLEDGEMENT AND RETURN FORM". and return to: FCA1@integralife.com or FAX to 1-609-275-9445. For questions contact Customer Service at 1-800-550-7155.
Quantity in Commerce 61
Distribution US Nationwide Distribution
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.
510(K) Database 510(K)s with Product Code = MBP and Original Applicant = ISOTIS ORTHOBIOLOGICS, INC
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