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.
Reported: April 8, 2020 Initiated: February 27, 2020 #Z-1634-2020
Product Description
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.
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.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 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.
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Smith & Nephew, Inc.. Units affected: 348 units.
Why was this product recalled? ▼
Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 8, 2020. Severity: Moderate. Recall number: Z-1634-2020.
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