NAVIO Soft Tissue Protector recall
NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed…
Why was NAVIO Soft Tissue Protector recalled?
Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed…
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 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.
- Recall date
- April 8, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)