Class II

Medical Device Recall: Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty

Tornier, Inc · August 29, 2024

Reason for Recall

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.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

38 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3309-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.