Recall Z-0721-2022 ยท OLO Orthopedic Stereotaxic Instrument
Orthosoft, Inc. dba Zimmer CAS
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
| Date | Jan 7, 2022 |
| Status | Open, Classified |
| Reason | The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention. |
| Root cause | Under Investigation by firm |
| Action | On January 7, 2022, the firm issued Urgent Medical Device Recall letters to all affected consignees. Customers were instructed to assist Zimmer Biomet sales representatives and quarantine all affected product. Product will be removed from customer facilities. Customers are responsible for forwarding the recall notice to any accounts who received further distribution. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will |
| Quantity | 14 units US; 132 units OUS |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110054 | NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE Zimmer Cas, Mar 24, 2011 |