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.
This recall has been terminated (originally issued February 27, 2020).
- Company
- Smith & Nephew Inc
- Recall Initiated
- February 27, 2020
- Terminated
- August 2, 2024
- Recall Number
- Z-1634-2020
- Quantity
- 348 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.
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.
Lot / Code Info
Component Product Number: PFSR101092; a. Instrument Kit Number: PFSR02050, Lot Numbers 2067, 2212, 3809, 3869, 4354, 5228, 5337, 5494, 5514, 5887, 6248; b. Instrument Kit Number: PFSR02051, Lot Numbers 4354, 5514; c. Instrument Kit Number: PFSR02052, Lot Numbers 4354, 5494, 6248; d. Instrument Kit Number: PFSR02053, Lot Numbers 6248
Root Cause
Device Design
Action Taken
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.