FDA recall Z-1035-2023

Product

Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case

Reason for recall

Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.

Distribution

US Nationwide distribution in the states of AR, MD, WA, WI.

Key facts

Status

Ongoing

Initiation date

2022-11-17

Report date

2023-02-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1035-2023