Zimmer Biomet recalls Vitality Spinal Fixation System pedicle screws due to manufacturing issue causing improper threading. Affected units include specific model numbers and lot numbers. Consumers should contact manufacturer for details.
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 pedicle screws because they may not thread properly with other components. This could lead to improper spinal fixation during surgery, potentially causing complications for patients who have received the device.
The shear-off set screw does not thread correctly with the mating tulip head of the screws, hooks, and connectors due to a manufacturing defect. This could result in improper spinal fixation during surgery, which may lead to complications such as instability or misalignment of the spine.
Patients who have received the recalled spinal fixation system components during surgery are most at risk. Orthopedic surgeons and their patients using the specific model numbers listed in the recall are affected.
Check for the specific model numbers and lot numbers listed in the recall: P141352 through P142510 and W505611 through W577991. The product is a non-sterile spinal fixation system used in orthopedic procedures.
Reach out to Zimmer Biomet Spine Inc. for specific details about your affected product and instructions on how to return or replace it.
The Vitality Shear-off Set Screw has a manufacturing issue causing it not to thread properly with the mating tulip head of the screws, hooks, and connectors.
Contact Zimmer Biomet Spine Inc. directly for details about your specific model and instructions on how to return or replace it.
The recall indicates a potential issue with threading, but the product is not considered unsafe for use in normal conditions. Affected units should be checked and addressed by the manufacturer.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0866-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0866-2019 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.
