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.
Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.
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.
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.
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.
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.
Identify the instrument kit number and lot numbers from the product labels to determine if your item is affected.
Yes, the protector may become stuck to bone pins during surgery, which could cause improper placement and complications.
The recall does not specify a remedy, so contact Smith & Nephew for guidance on next steps.
Instrument kits with model numbers PFSR02050, PFSR02051, PFSR02052, or PFSR02053 and specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1634-2020 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1634-2020 from Smith & Nephew. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
