FDA Medical devices recall ·
BIORAPTOR Suture Anchors recall
- Recall number
- Z-0581-2025
- Date
- (initiated October 29, 2024)
- Company / brand
- Smith & Nephew, Inc.
150 Minuteman Rd, Andover, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2,156 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Why was it recalled?
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.
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.
States: Alaska Alabama California Illinois Indiana Kentucky Maryland Minnesota North Carolina Nebraska New Hampshire New Jersey Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0581-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.