FDA recall Z-3309-2024

Tornier, Inc · Class II · device

Product

Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty

Reason for recall

Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-08-29
Report date
2024-10-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bloomington, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3309-2024