FDA-Device2017-05-17Class II

Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, 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 PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2042-2017

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