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Tornier, Inc recalls Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Recalled October 9, 2024 · FDA recall Z-3309-2024 · Tornier
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. · FDA Class II
Units
38 units
Sold at
US Nationwide distribution.
Description
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.
Product
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Manufacturer(s)
Tornier, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →