Recall Z-0039-2020 ยท FTM Mesh, Surgical
AZIYO BIOLOGICS
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)
| Date | Aug 21, 2019 |
| Status | Terminated |
| Reason | Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device. |
| Root cause | 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 tele |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140306 | CORMATRIX PROTECT ECM ENVELOPE Cormatrix Cardiovascular, Inc., Aug 15, 2014 |