PlainRecalls
FDA Devices Moderate Class II Terminated

Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm

Reported: May 17, 2017 Initiated: March 24, 2017 #Z-2045-2017

Product Description

Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm

Reason for Recall

Some eyelets broke from SwiveLock Anchor on insertion.

Details

Recalling Firm
Arthrex, Inc.
Units Affected
N/A
Distribution
AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD)
Location
Naples, FL

Frequently Asked Questions

What product was recalled?
Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm. Recalled by Arthrex, Inc.. Units affected: N/A.
Why was this product recalled?
Some eyelets broke from SwiveLock Anchor on insertion.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 17, 2017. Severity: Moderate. Recall number: Z-2045-2017.