FDA Device Recall Z-0039-2020: AZIYO BIOLOGICS

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0039-2020.

Recall Res Number

Z-0039-2020

Recalling Firm / Manufacturer

AZIYO BIOLOGICS

FEI Number

3005619880

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2019-08-21

Date Posted

N/A

Date Terminated

2020-09-17

Product Code

FTM

Event Number

83652

Product Quantity

1018 units

Product Description 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.

Reason for Recall Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.

Action Details 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.

Distribution Pattern 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.

Code Information / Serial Numbers 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

Related Establishments / Registrations

COOK INCORPORATED Registration: 1000393132 View Registration
C.R. BARD, INC. Registration: 1018233 View Registration
Sterigenics U.S., LLC Registration: 1018470 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
STERILIZATION SERVICES OF GEORGIA, INC. Registration: 1048735 View Registration
S. JACKSON, INC. Registration: 1111225 View Registration
INTEGRA LIFESCIENCES CORPORATION Registration: 1121308 View Registration
DAVOL INC., SUB. C.R. BARD, INC. Registration: 1213643 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
LEMAITRE VASCULAR, INC. Registration: 1220948 View Registration
ORGANOGENESIS INC. Registration: 1221816 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1319660 View Registration
BAXTER HEALTHCARE CORPORATION Registration: 1416980 View Registration
Isomedix Operations, Inc. Registration: 1450662 View Registration
Sterigenics US, LLC Registration: 1526534 View Registration
VWR CHEMICALS, LLC Registration: 1550222 View Registration
LIFECELL CORP. Registration: 1647098 View Registration
TORNIER, INC. Registration: 1649390 View Registration
DEPUY ORTHOPAEDICS, INC. Registration: 1818910 View Registration
Cook Incorporated Registration: 1820334 View Registration
COOK BIOTECH, INC. Registration: 1835959 View Registration
Amcor Flexibles, Commerce Registration: 2023811 View Registration
Sterigenics Radiation Technologies, LLC Registration: 2024024 View Registration
Synergy Health AST, LLC Registration: 2030598 View Registration
Boston Scientific Corporation Registration: 2124215 View Registration
Stellen Medical, LLC Registration: 2132242 View Registration
SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.) Registration: 2183620 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
LYNX Medical NJ Registration: 2244478 View Registration
ISOMEDIX OPERATIONS INC. Registration: 2245304 View Registration
Isomedix Operations Inc. Registration: 2246552 View Registration
COLLAGEN MATRIX, INC. Registration: 2249852 View Registration
DSM Biomedical, Inc. Registration: 2530154 View Registration
ALLOSOURCE Registration: 3000215346 View Registration
Tornier S.A.S. Registration: 3000931034 View Registration
RTI Surgical, Inc. (dba RTI Biologics, Inc.) Registration: 3002719998 View Registration
MEDTRONIC B.V. (EOC) Registration: 3002807561 View Registration
Tutogen Medical GmBH Registration: 3002924436 View Registration
Collagen Matrix, Inc Registration: 3003300673 View Registration
Integra LifeSciences Corporation Registration: 3003418325 View Registration
SMITH & NEPHEW INC. Registration: 3003604053 View Registration
PFM MEDICAL TITANIUM GMBH Registration: 3003936139 View Registration
Integra LifeSciences Braintree Inc. Registration: 3004170064 View Registration
DEPUY ORTHOPAEDICS Registration: 3004464325 View Registration
Sterigenics Belgium Fleurus SA Registration: 3004681519 View Registration
MICRO PRECISION SWISS Registration: 3005497913 View Registration
Boston Scientific Corporation Registration: 3005619880 View Registration
BARD SHANNON LIMITED Registration: 3005636544 View Registration
ACELL, INC. Registration: 3005920706 View Registration
BBF STERILISATIONSSERVICE GMBH Registration: 3006017180 View Registration
Aroa Biosurgery Ltd Registration: 3007321028 View Registration
Synthes (USA) Products LLC Registration: 3008812560 View Registration
EXEL INC. DBA DHL SUPPLY CHAIN (USA) Registration: 3008868758 View Registration
HA2 MEDIZINTECHNIK GMBH Registration: 3009039068 View Registration
SYNTHES GMBH Registration: 3009417901 View Registration
Viant Medical, Inc. Registration: 3009493875 View Registration
Sterigenics Radiation Technologies IN, Inc Registration: 3009504230 View Registration
Synergy Health AST, LLC Registration: 3009882464 View Registration
Synergy Health Sterilisation UK Ltd Registration: 3010155661 View Registration
IONISOS Registration: 3010178296 View Registration
TRIBE MEDICAL GROUP Registration: 3010400367 View Registration
TELA BIO, INC. Registration: 3010513348 View Registration
KERECIS EHF Registration: 3010600625 View Registration
Reprise Biomedical, Inc. Registration: 3010894343 View Registration
Synergy Health AST, LLC Registration: 3012102437 View Registration
Arthrocare Corporation Registration: 3012358417 View Registration
STERI-TEK Registration: 3012448339 View Registration
COLORADO THERAPEUTICS LLC Registration: 3012547639 View Registration
ALAFAIR BIOSCIENCES, INC. Registration: 3012669262 View Registration
ABBVIE Logistics BV, Inc Registration: 3013307971 View Registration
PFM Medical, Inc Registration: 3013666218 View Registration
Isomedix Operations Inc. Registration: 3013820501 View Registration
BURAK GLOBAL IC VE DIS TIC LTD STI Registration: 3014461810 View Registration
BRIDGEMED SOLUTIONS, INC. Registration: 3015413883 View Registration
Medtronic Neurosurgery Registration: 3015531529 View Registration
Embody, Inc. Registration: 3015543569 View Registration
TISGENX, INC. Registration: 3016003911 View Registration
KERECIS EHF Registration: 3016429246 View Registration
LIFECELL CORP Registration: 3016823837 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
TYBR HEALTH, INC. Registration: 3027383505 View Registration
Collagen Matrix, Inc. Registration: 3027448274 View Registration
FESARIUS THERAPEUTICS Registration: 3036710971 View Registration
STRYKER LEIBINGER GMBH & CO. KG Registration: 8010177 View Registration
STERIS Schweiz AG Registration: 8043792 View Registration
GEISTLICH PHARMA AG Registration: 9614442 View Registration
SOFRADIM PRODUCTION Registration: 9615742 View Registration
PFM Medical GmbH Registration: 9617465 View Registration
Sterigenics Radiation Technologies Canada, Inc Registration: 9680579 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0039-2020

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer