Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle

FDA Recall Z-1383-2022 · Posted None

Recalling FirmAesculap Implant Systems LLC
Recall StatusTerminated
Product CodeHXK
Date Initiated2019-09-25
Date Terminated2024-04-01
Product Quantity7 pieces

Reason for Recall

Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.

Firm Action

Field Action Notification letter was issued September 25, 2019 via letter sent USPS certified mail with return receipt. Customers are to review inventory, return affected product and the acknowledgement form. For questions contact (800) 282-9000 or via email at: [email protected]

Root Cause

Labeling Change Control

Distribution Pattern

United States: TX and AK

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑