Z-0070-2019 Class II Terminated
FDA device recall Z-0070-2019 was initiated by COVIDIEN LLC on Aug 17, 2018 and is designated Class II. Reason for recall: The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove… The recall status is terminated (terminated Apr 10, 2020). Affected quantity: 1,902.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 10, 2018
- Initiation Date
- Aug 17, 2018
- Termination Date
- Apr 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,902
Product Description
EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.
Reason for Recall
The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of CA, FL, IL, NC, NY, UT. and the countries of Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Reunion, Spain, Sweden, Switzerland, and United Kingdom.
Code Information
P8A0976X P8A0977X P8A0978X P8A0979X P8A0980X P8A0981X P8B1538X P8B1539X P8B1540X P8B1541X P8B1542X P8C0032X P8C0033X P8C1177X P8C1178X P8C1179X P8C1180X P8C1181X P8C1183X P8D1405X P8D1406X P8D1407X P8D1408X P8D1409X P8D1410X P8D1411X P8E1211X P8E1212X P8E1213X P8E1214X P8E1215X P8E1216X P8E1217X P8E1304X P8E1305X
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0070-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026