Recall Z-1542-2020— T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.

Class II · Terminated

Class II FDA medical device recall by T.A.G. MEDICAL PRODUCTS CORPORATION, LTD., initiated 2020-01-20, terminated 2025-04-21. FDA's recall record names no specific 510(k) clearance for this event. Product: FlipCutter III Drill. Reason: There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier..

Recalling firm
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Classification
Class II
Status
Terminated
Initiated
2020-01-20
Terminated
2025-04-21
Firm location
Naharia, N/A, Israel

Product description

FlipCutter III Drill

Reason for recall

There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier.

Data sourced from openFDA. This site is unofficial and independent of the FDA.