Recall Z-1383-2022— Aesculap Implant Systems LLC
Class II · Terminated
Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2019-09-25, terminated 2024-04-01. FDA's recall record names no specific 510(k) clearance for this event. Product: AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle. Reason: Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM..
- Recalling firm
- Aesculap Implant Systems LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-09-25
- Terminated
- 2024-04-01
- Firm location
- Center Valley, PA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.