Aesculap Implant Systems LLC: Medical Device Recall in 2022 - (Recall #: Z-1383-2022)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2022.
Data Source: FDA.
Product Description:
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
Product Classification:
Class II
Date Initiated: September 25, 2019
Date Posted: July 20, 2022
Recall Number: Z-1383-2022
Event ID: 90483
Reason for Recall:
Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
Status: Terminated
Product Quantity: 7 pieces
Code Information:
UDI-DI (GTIN): 04046955063277
Distribution Pattern:
United States: TX and AK
Voluntary or Mandated:
Voluntary: Firm initiated