BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Reported: December 11, 2024 Initiated: October 29, 2024 #Z-0581-2025
Product Description
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Reason for Recall
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Details
- Recalling Firm
- Smith & Nephew Inc.
- Units Affected
- 2,156 units
- 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.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.. Recalled by Smith & Nephew Inc.. Units affected: 2,156 units.
Why was this product recalled? ▼
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 11, 2024. Severity: Moderate. Recall number: Z-0581-2025.
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