FDA-Device2024-10-09Class II
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Tornier, Inc
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
38 units
Manufactured in
10801 Nesbitt Ave S, N/A, Bloomington, MN, United States
Products
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3309-2024Don't want to check this manually?
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