Smith & Nephew Recalls NAVIO Soft Tissue Protector Due to Binding Risk
Smith & Nephew is recalling 348 NAVIO Soft Tissue Protectors because the instrument may become stuck to bone pins during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (intraoperative binding) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Smith & Nephew, Inc. is recalling 348 units of the NAVIO Soft Tissue Protector, a reusable instrument included in instrument kits. The device is designed to provide required bone pin spacing for Navio bone clamps and potentially reduce the amount of patient tissue affected when placing bone pins.
The recall is being conducted because the NAVIO Soft Tissue Protector has the potential to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins. The affected units are distributed nationwide to 28 states and internationally to Turkey, the United Kingdom, Thailand, Switzerland, France, and Australia.
The affected product is identified by Component Product Number PFSR101092. Specific instrument kit numbers and lot numbers are listed in the structured product information. Healthcare providers and facilities should stop using the affected instruments and contact Smith & Nephew for instructions on return or replacement.
The recalled product
- 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 whe
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 348
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 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
- c. Instrument Kit Number: PFSR02052
- d. Instrument Kit Number: PFSR02053
- Lot Numbers 6248
Distribution
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