FDA-Device2017-05-17Class II

Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching

Arthrex, Inc.
Hazard

Some eyelets broke from SwiveLock Anchor on insertion.

Sold states
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)
Affected count
N/A
Manufactured in
1370 Creekside Blvd, N/A, Naples, FL, United States
Products
Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2046-2017

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