DePuy Spine recalls Confidence Plus Spinal Cement kits with certain lot numbers due to potential incorrect contrast medium levels, making them difficult to see on x-rays during medical procedures.
Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray.
DePuy Spine is recalling specific lots of their Confidence Plus Spinal Cement System kits because they may contain incorrect amounts of contrast medium. This makes the cement hard to visualize on x-rays, which could lead to improper surgical placement and complications during spinal procedures.
The spinal cement may contain incorrect amounts of contrast medium, which makes it difficult to see on x-ray images. This could lead to improper placement during surgery, potentially causing complications like cement leakage or inaccurate fracture fixation.
Patients undergoing spinal procedures like vertebroplasty or kyphoplasty who use the recalled kits with specific lot numbers are most at risk. Medical professionals using these kits for vertebral fracture fixation are also affected.
Check the product's lot numbers: 129385 through 154957 and HVKBHH, HVKBHJ. The kit is labeled as the CONFIDENCE SPINAL CEMENT SYSTEM 11cc Kit for spinal procedures.
Look for lot numbers on the kit: 129385 through 154957 and HVKBHH, HVKBHJ.
The spinal cement may contain incorrect amounts of contrast medium, making it difficult to visualize on x-ray during surgery.
Check the product's lot numbers to see if it's affected. If it is, contact DePuy Spine for further instructions.
The recall is for specific lots that may have incorrect contrast medium levels. Not all kits are affected.
We’ve drafted a message you can send DePuy Spine to request your refund or repair — edit it as you like.
Subject: Recall Z-1300-2018 — DePuy Spine DePuy Spine Hello, I own a DePuy Spine that is covered by recall Z-1300-2018 from DePuy Spine. 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.
