FDA-Device2023-10-25Class II
stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Tornier, Inc
Hazard
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.
Sold states
US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN
Affected count
30 units
Manufactured in
10801 Nesbitt Ave S, N/A, Bloomington, MN, United States
Products
stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0113-2024Don't want to check this manually?
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