Class II

Medical Device Recall: BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

Smith & Nephew Inc. · October 29, 2024

Reason for Recall

Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

Distribution

Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR.

States Affected

NATIONWIDE

Quantity Affected

2,156 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0581-2025

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.