Recall Z-2046-2017 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
Arthrex, Inc.
Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
| Date | Mar 24, 2017 |
| Status | Terminated |
| Reason | Some eyelets broke from SwiveLock Anchor on insertion. |
| Root cause | Under Investigation by 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 Complaints@Arthrex.comor 866-267-9138 |
| 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, So |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101823 | ARTHREX SWIVELOCK ANCHORS Arthrex, Inc., Jan 7, 2011 |