Class II

Medical Device Recall: stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder

Tornier, Inc · August 29, 2024

Reason for Recall

One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).

Distribution

US Nationwide distribution in the states of IL, WI, AZ, NV, SD.

States Affected

NATIONWIDE

Quantity Affected

5 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3155-2024

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.