—#180115

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.

FDA product code: OLO — Orthopedic Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K121936
Affected 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

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-02-27
Terminated: 2024-08-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180115. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.