Recall Z-2303-2020 ยท HWC Screw, Fixation, Bone
Biomet
Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
| Date | May 14, 2020 |
| Status | Terminated |
| Reason | Distributed to the field without having completed design history files or design transfer activities |
| Root cause | Device Design |
| Action | Zimmmer Biomet issued Urgent Medical Device Recall letter , dated May 14, 2020 to Risk Manger, Distributors,Surgeons, stating reason for recall, health risk and action to take: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbi |
| Quantity | 6 OUS |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140891 | BIOMET CANNULATED SCREW SYSTEM Biomet, Inc., Jun 3, 2014 |