Smith & Nephew NAVIO Soft Tissue Protector Recall: Risk of Bone Pin Sticking During
Smith & Nephew recalls NAVIO Soft Tissue Protectors in specific instrument kits due to potential bone pin sticking during surgery. Affected kits have listed lot numbers; contact for remedy.
Use caution until it’s fixed
Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.
Contact the company
What happened, in plain English
Smith & Nephew is recalling certain NAVIO Soft Tissue Protectors that may stick to bone pins during surgery. This could cause complications for patients during procedures. The recall affects specific instrument kits with listed lot numbers. Read more at govinfonow.com/recall/65735-smith-nephew-navio-soft-tissue-protector-recall-risk-of-bone.
Source Summary by GovInfoNow · govinfonow.com/recall/65735-smith-nephew-navio-soft-tissue-protector-recall-risk-of-bone · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1634-2020
Cite this page
“Smith & Nephew NAVIO Soft Tissue Protector Recall: Risk of Bone Pin Sticking During.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65735-smith-nephew-navio-soft-tissue-protector-recall-risk-of-bone. Based on FDA recall #Z-1634-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1634-2020%22&limit=1).
Why it’s dangerous
The protector may become stuck to bone pins while inserting them during surgery. This could cause improper bone pin placement and lead to surgical complications. The hazard occurs only during specific surgical procedures.
Who’s affected
Surgical teams using the recalled NAVIO Soft Tissue Protectors in instrument kits are most at risk. Patients undergoing procedures with these kits may face complications if the protector sticks to bone pins.
How to tell if you have this one
Check the instrument kit number and lot numbers listed in the recall notice. The affected kits include specific model numbers and lot numbers like PFSR02050 with lots 2067, 2212, etc.
- Brand
Smith & Nephew- Category
Medical device
What to do — step by step
Check Kit Details
Identify the instrument kit number and lot numbers from the product labels to determine if your item is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 28 states.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Iowa, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Montana, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 4.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1634-2020 (February 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1634-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.