Zimmer Biomet recalls certain Vitality Spinal Fixation System screws due to improper threading that could cause device failure during spinal fusion surgery.
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 specific Vitality Spinal Fixation System screws because they don't thread properly with other components. This could lead to the device failing during spinal fusion surgery, which is serious for patients needing spinal procedures.
The shear-off set screw has a manufacturing defect that prevents it from threading correctly with the mating tulip head of the screws, hooks, and connectors. This could cause the device to fail during spinal fusion surgery, potentially leading to complications like improper fixation or the need for additional surgery.
Patients who have received the recalled Vitality Spinal Fixation System screws for spinal fusion procedures are affected. Surgeons and medical staff using these screws in procedures are at highest risk.
Check for the item numbers P141352 through P142510 and W505611 through W577991 on the packaging or device labels. These specific screws were manufactured in batches between 2020 and 2021.
Look for the item numbers P141352 through P142510 and W505611 through W577991 on the packaging or device labels.
Reach out to Zimmer Biomet Spine Inc. for guidance on whether your device is affected and what steps to take next.
The shear-off set screw has a manufacturing defect that prevents it from threading properly with the mating tulip head of the screws, hooks, and connectors.
Check your device labels for the item numbers P141352 through P142510 and W505611 through W577991. Contact Zimmer Biomet Spine Inc. for guidance.
Yes, improper threading could cause the device to fail during spinal fusion surgery, potentially requiring additional procedures.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0868-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0868-2019 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.
