FDAFDA · Food and drugs·Recall number Z-0581-2025
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Published December 11, 2024 · Recall initiated: October 29, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Smith & Nephew Inc.
- Distributor
- 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.
- Lot
- Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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