Arthrex Recalls Anthrex SpeedBridge Implant System Due to Broken Eyelets
Arthrex, Inc. is recalling the Anthrex SpeedBridge Implant System because some eyelets broke from the SwiveLock Anchor 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 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 where injury has not yet been reported.
Plain-English summary
Arthrex, Inc. is recalling the Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching. The recall was initiated because some eyelets broke from the SwiveLock Anchor on insertion.
The affected product is identified by Unique Device Identifier 00888867160231 and Batch Number 10070003, with an expiration date of 9/30/2021. The product was distributed in numerous U.S. 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).
Consumers and healthcare providers should stop using the affected product and contact Arthrex, Inc. for further instructions.
The recalled product
- Product
- Anthrex SpeedBridge Implant System with PEEK SwiveLock 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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