Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
FDA Recall Z-0818-2018 · Posted None
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Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeMBI
Date Initiated2017-08-22
Date Terminated2020-05-12
Product Quantity885 units total
Reason for Recall
Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors.
Firm Action
Customers were notified via letter on about 08/22/2017. Instructions for distributors, sales representatives, and distributor operation managers include to ensure affected personnel are aware of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return affected product, and identify any additional hospitals or surgeons that should be notified.
Instructions for surgeons and risk managers include to ensure affected personnel are aware of the recall, identify and quarantine any affected product on hand, complete and return the Certificate of Acknowledgement, return any affected product.
Questions or concerns can be addressed to the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST, Monday through Friday. Additionally, questions may be sent by email to [email protected].
Root Cause
Packaging process control
Distribution Pattern
Distributed domestically to AK, AL, AR, AZ, CA, CO, FL, ID, IN, KY, MA, MD, ME, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI. Distributed internationally to ARGENTINA, AUSTRALIA, CANADA, COSTA RICA, JAPAN, NETHERLANDS.
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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