FDA recall Z-1139-2021

Product

Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 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-1139-2021