FDA recall Z-1542-2020

Product

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.

Distribution

Product distributed throughout the United States, Austria, Australia, Bermuda, Switzerland, China, Germany, Denmark, France, Great Britain, Italy, Netherlands, Poland, Sweden and Taiwan.

Key facts

Status

Terminated

Initiation date

2020-01-20

Report date

2020-04-01

Termination date

2025-04-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Naharia, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1542-2020