FDA-Device2024-12-11Class II
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Smith & Nephew Inc.
Hazard
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Sold states
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.
Affected count
2,156 units
Manufactured in
150 Minuteman Rd, Andover, MA, United States
Products
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0581-2025Don't want to check this manually?
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