Reported Apr 8, 2020 · Terminated
NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed…
Smith & Nephew, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804
Is this the product you have?
- 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.
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Instrument Kit Number: PFSR02050, Lot Numbers 2067, 2212, 3809, 3869, 4354, 5228, 5337, 5494, 5514, 5887, 6248 2 Instrument Kit Number: PFSR02051, Lot Numbers 4354, 5514 3 Instrument Kit Number: PFSR02052, Lot Numbers 4354, 5494, 6248 4 Instrument Kit Number: PFSR02053, Lot Numbers 6248 - Amount recalled
- 348 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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