Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
FDA Recall Z-2046-2017 · Posted None
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Recalling FirmArthrex, Inc.
Recall StatusTerminated
Product CodeMAI
Date Initiated2017-03-24
Date Terminated2019-11-04
Reason for Recall
Some eyelets broke from SwiveLock Anchor on insertion.
Firm Action
On March 24, 2017, Arthrex contacted all distributors that received potentially affected device and instructed them to place the product in quarantine. On March 27th, 2017, Distributors were instructed to return the affected device to Arthrex. Call Arthrex Customer Service at 855-552-5056 for returned goods authorization (RGA) and product return instruction. Please complete the Recall Acknowledge of Receipt postal card included in the notification. Any questions contact [email protected] 866-267-9138
Root Cause
Under Investigation by firm
Distribution Pattern
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)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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