Arthrex SpeedBridge Implant System Recalled for Broken Eyelets
Arthrex is recalling specific SpeedBridge Implant Systems because some eyelets broke during insertion. The recall covers multiple batches distributed in the US and internationally.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or structural defects in medical devices are rated as Severe (4).
Plain-English summary
Arthrex, Inc. is recalling the Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm. The recall is due to reports that some eyelets broke from the SwiveLock Anchor during insertion.
The affected product includes specific batch numbers with expiration dates ranging from late 2017 to late 2018. The distribution pattern includes numerous US states, Puerto Rico, and several international locations including Australia, Canada, and Germany.
No specific instructions for consumers are provided in the source text, but the recall is classified as Class II by the FDA. Patients who have had this specific implant system inserted should consult their healthcare provider regarding the recall.
The recalled product
- Product
- Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
- 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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