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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Smith & Nephew, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Smith & Nephew, Inc. is recalling NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusab due to Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026