Smith & Nephew Inc. recalls BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
- Recall date
- October 29, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0581-2025
- FDA classification
- Class II
- Brand / firm
- Smith & Nephew Inc.
- Sold / distributed
- 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.
Why it was recalled
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Get recall alerts
Free email alert whenever Smith & Nephew Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Smith & Nephew Inc.