Arthrex Bio-SwiveLock SP Vented Anchor Recall Due to Broken Eyelets
Arthrex, Inc. is recalling specific Bio-SwiveLock SP Vented 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 functional defect (broken eyelets) that poses a risk of harm during insertion, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Arthrex, Inc. is recalling the Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching anchor. The recall is being conducted because some eyelets broke from the SwiveLock Anchor during insertion.
The affected devices are identified by the Unique Device Identifier 00888867026766, Batch Number 1078259, and an expiration date of 11/30/2018. These products were distributed to various locations in the United States, Puerto Rico, and several international countries including Australia, Canada, and Germany.
Healthcare providers and patients should stop using the affected devices and contact Arthrex, Inc. for further instructions or a replacement.
The recalled product
- Product
- Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
- Manufacturer
- Arthrex, Inc.
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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