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U.S. Department of Health and Human Services

Class 2 Device Recall BioEnvelope

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  Class 2 Device Recall BioEnvelope see related information
Date Initiated by Firm August 21, 2019
Create Date October 04, 2019
Recall Status1 Terminated 3 on September 17, 2020
Recall Number Z-0039-2020
Recall Event ID 83652
510(K)Number K140306  
Product Classification Mesh, surgical - Product Code FTM
Product BioEnvelope, surgical mesh envelope. Labeled as the following:

1. BioEnvelope (Medium) (single pack);

2. BioEnvelope (Large) (single pack);

3. BioEnvelope (Extra Large) (single pack);

4. BioEnvelope (Extra Extra Large) (single pack);

5. BioEnvelope (Large) (5-pack);

6. BioEnvelope (Medium) (5-pack);

7. BioEnvelope (Extra Extra Large) (5-pack);

8. BioEnvelope (Extra Large) (5-pack)

Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Code Information 1. Catalog Number 440576 (UDI Number 004035479160524) Lot Numbers: M18A1010, M18A1022, M18C1070, M18G1185;   2. Catalog Number 440577 (UDI Number 004035479160531) Lot Number M18A1021;   3. Catalog Number 440578 (UDI Number 004035479160548) Lot Numbers: M18A1008, M18B1051, M18G1181;   4. Catalog Number 440579 (UDI Number 004035479160555) Lot Numbers: M18F1146, M18G1188;   5. Catalog Number 440622 (UDI Number 004035479160616) Lot Numbers: M18A1007, M18D1080;   6. Catalog Number 440623 (UDI Number 004035479160623) Lot Numbers: M18A1015, M18C1071;   7. Catalog Number 440625 (UDI Number 004035479160647) Lot Number M18G1189;   8. Catalog Number 440626 (UDI Number 004035479160654) Lot Numbers: M18A1014; M18B1054   
Recalling Firm/
Manufacturer		 AZIYO BIOLOGICS
1100 Old Ellis Rd
Roswell GA 30076-4992
For Additional Information Contact
877-651-2628
Manufacturer Reason
for Recall		 Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
FDA Determined
Cause 2		 Under Investigation by firm
Action Aziyo Biologics notified customers on about 08/26/2019 via letter. The letter informed customers of potential suture brittleness or breakage along the envelope seam prior to the expiration of the device. Customers were instructed to immediately discontinue use of affected lots and return them to Aziyo for replacement at no cost. Customers are directed to contact Customer Service at 877-651-2628 to initiate the return, using RGA # 19-1994R. Additionally, customers are instructed to acknowledge of receipt of the recall notice by email (customerservice@aziyo.com), fax (678-680-5486), or telephone (877-651-2628), and return of the Acknowledgement and Receipt Form attached to the recall notification. An updated consignee letter was sent on about 09/04/2019. The letter contained the same information and instructions but notified customers that this action was a removal and not a market withdrawal.
Quantity in Commerce 1018 units
Distribution US Nationwide distribution including the states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, LA, MI, MN, MO, MS, NC, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI.
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 = FTM and Original Applicant = CORMATRIX CARDIOVASCULAR, INC.
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