Z-1383-2022 Class II Terminated
FDA device recall Z-1383-2022 was initiated by Aesculap Implant Systems LLC on September 25, 2019 and is designated Class II. Reason for recall: Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM. The recall status is terminated (terminated April 1, 2024). Affected quantity: 7 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- July 20, 2022
- Initiation Date
- September 25, 2019
- Termination Date
- April 1, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 pieces
Product Description
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
Reason for Recall
Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
Distribution Pattern
United States: TX and AK
Code Information
UDI-DI (GTIN): 04046955063277