PlainRecalls
FDA Devices Moderate Class II Terminated

FlipCutter III Drill

Reported: April 1, 2020 Initiated: January 20, 2020 #Z-1542-2020

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.

Details

Units Affected
6625 units
Distribution
Product distributed throughout the United States, Austria, Australia, Bermuda, Switzerland, China, Germany, Denmark, France, Great Britain, Italy, Netherlands, Poland, Sweden and Taiwan.
Location
Naharia, N/A

Frequently Asked Questions

What product was recalled?
FlipCutter III Drill. Recalled by T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.. Units affected: 6625 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 1, 2020. Severity: Moderate. Recall number: Z-1542-2020.