FDA recall Z-1098-2023

Zimmer, Inc. · Class II · device

Product

Identity Shoulder System Resection Planer 35mm Resection Planer

Reason for recall

Two planers were found to be unusable during sawbones shoulder training.

Distribution

US Nationwide distribution in the states of AR, CA, IL, MI, NJ, NY, OK, PA, TX, and WA.

Key facts

Status
Ongoing
Initiation date
2022-12-07
Report date
2023-02-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1098-2023