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Recall

Class II — Arthrex, Inc.

Recalling firmARTHREX, INC.
Registered facilityView this company's 20 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonSome eyelets broke from SwiveLock Anchor on insertion.
ProductAnthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
QuantityN/A
DistributionAK, 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)
Initiated2017-03-24
Classified2017-05-05
Terminated2019-11-04
Recall numberZ-2046-2017
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Arthrex, Inc. (Z-2046-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76986/

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