Zimmer Biomet recalls Vitality Spinal Fixation System components due to shear-off set screw not threading correctly with other parts. This manufacturing issue may affect spinal surgery procedures.
The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications
Zimmer Biomet is recalling certain Vitality Spinal Fixation System components because the shear-off set screw doesn't thread properly with the Vitality screws and connectors. This could lead to improper spinal fixation during surgery.
The shear-off set screw has a manufacturing defect that prevents it from threading correctly with the mating tulip head of the Vitality screws and connectors. This could cause improper spinal fixation during surgery, potentially leading to complications.
Orthopedic surgeons and medical professionals who use the Vitality Spinal Fixation System for spinal fusion procedures. Patients undergoing spinal surgery with these components are at risk.
Check for the item numbers P141352 through P142510 and W505611 through W577991 on the Vitality Shear-off Set Screw packaging. These items were sold between unspecified dates.
Immediately discontinue use of the recalled Vitality Shear-off Set Screws with the specified item numbers.
The shear-off set screw does not thread properly with the mating tulip head of the Vitality screws and connectors due to a manufacturing issue.
Over 20,000 units were manufactured with the affected item numbers.
The recall record does not specify a remedy or replacement option.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0867-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0867-2019 from Zimmer Biomet. 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.
