FDA recall Z-1140-2021

DeRoyal Industries Inc · Class II · device

Product

Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades.

Reason for recall

Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.

Distribution

Distributors in OK, MI, and TX.

Key facts

Status
Terminated
Initiation date
2021-01-25
Report date
2021-03-03
Termination date
2022-07-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1140-2021