FDA recall Z-1934-2024

Product

LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert

Reason for recall

Due to unsupported 10 year expiration date.

Distribution

US Nationwide distribution in the states of AL, AZ, CA, MI, PA, TX.

Key facts

Status

Ongoing

Initiation date

2024-03-29

Report date

2024-06-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cheonan, N/A, Korea (the Republic of)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1934-2024