Recall Z-1634-2020 ยท OLO Orthopedic Stereotaxic Instrument
Smith & Nephew, Inc.
NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected when placing the bone pins.
| Date | Feb 27, 2020 |
| Status | Terminated |
| Reason | Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins. |
| Root cause | Device Design |
| Action | The firm, Smith & Nephew, notified customers on about 03/03/2020 via "Urgent Medical Device Recall Notice" letter. The customers were Instructed to examine inventory and quarantine affected devices, notify customers if further distributed, and complete and return the Response Form to fieldactions@smith-nephew.com or fax to 1-901-566-7975. Questions and concerns can be directed to EieldActions@smlth-nephew .com. or 901-399-1970. |
| Quantity | 348 units |
| Distribution | Nationwide distribution to AL, AZ, CA, CT, FL, GA, HI, IA, IL, KS, LA, MA, MI, MN, MS, MT, NC, NJ, NY, OH, OK, PA, TN, TX, VA, WA, WI, WV. International distribution to Turkey, United Kingdom, Thailand, Switzerland, France, Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121936 | NAVIOPFS Blue Belt Technologies, Inc., Nov 30, 2012 |