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Smith & Nephew Inc. recalls BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Recalled December 11, 2024 · FDA recall Z-0581-2025 · Smith & Nephew
Hazard
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device. · FDA Class II
Units
2,156 units
Sold at
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.
Description
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Product
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Manufacturer(s)
Smith & Nephew Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →