Arthrex Bio Composite SwiveLock Anchor Eyelets Break on Insertion
Arthrex is recalling specific batches of Bio Composite SwiveLock anchors because some eyelets broke during insertion.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical failure (eyelets breaking) that poses a risk of harm during a surgical procedure, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arthrex, Inc. is recalling the Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching anchor. The recall is due to reports that some eyelets broke from the SwiveLock Anchor on insertion.
The affected product is distributed in the United States, Puerto Rico, and several international locations including Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay, and Japan (DOD). Specific batch numbers and expiration dates are listed in the recall documentation.
Healthcare providers should stop using the affected devices and contact Arthrex for further instructions. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
- Manufacturer
- Arthrex, Inc.
- Hazard
Distribution
Part of a larger recall action
This product is one of 6 recalled by Arthrex, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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