Arthrex Recalls Anthrex PEEK SwiveLock SP Vented Anchors Due to Breakage
Arthrex, Inc. is recalling specific Anthrex PEEK 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 is classified as FDA Class II, and the hazard involves a structural failure of a medical device during insertion, which poses a risk of harm even though specific injuries are not detailed in the source text.
Plain-English summary
Arthrex, Inc. is recalling the Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching anchor. The recall is being conducted because some eyelets broke from the SwiveLock Anchor during insertion.
The affected product is identified by the Unique Device Identifier 00888867026926 and Batch Number 10072597, with an expiration date of 10/31/2021. The product was distributed to various locations in the United States, Puerto Rico, and several international countries including Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, and Uruguay, as well as Japan (DOD).
Healthcare providers and patients should stop using the affected anchors and contact Arthrex, Inc. for further instructions or replacement.
The recalled product
- Product
- Anthrex PEEK 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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