BIORAPTOR Suture Anchors. Tendon/ligament recall: Sterility Concern
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Why was BIORAPTOR Suture Anchors. Tendon/ligament recalled?
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.
- Product
- BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
- Recalling firm
- Smith & Nephew Inc.
- Quantity
- 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.
- Recall date
- December 11, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)