Recall Z-0818-2018 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Zimmer Biomet, Inc.
Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
| Date | Aug 22, 2017 |
| Status | Terminated |
| Reason | Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors. |
| Root cause | Packaging process control |
| 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 retur |
| Quantity | 885 units total |
| Distribution | 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. |
| FDA record | Open on fda.gov |