medical Class II Updated 2020-04-08

Smith & Nephew, Inc. recalls NAVIO Soft Tissue Protector, included in instrument kits.

Recalled 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.

Hazard / Issue

Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.

Issued by

FDA

Distribution: Nationwide (United States)
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
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