FDA recall Z-0113-2024

Product

stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502

Reason for recall

One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate.

Distribution

US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN

Key facts

Status

Ongoing

Initiation date

2023-09-15

Report date

2023-10-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0113-2024