FDA recall Z-0773-2024

Tornier, Inc · Class II · device

Product

Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.

Reason for recall

The incorrect device is contained in the labeled package.

Distribution

Distribution was made to AR, AZ, CA, CO, CT, NC, OH, TN, and VA. There was no military/government distribution. Foreign distribution was made to Australia, France, and Italy.

Key facts

Status
Ongoing
Initiation date
2024-01-03
Report date
2024-01-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bloomington, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0773-2024