Vital

Zimmer Biomet

Not determinedIndexed from FDA records

MR Conditional — conditions not yet documented here. We have a Conditional label for this device but the specific scan conditions (field strength, SAR / B1+rms, monitoring requirements) aren't in our records yet. Treat as Not determined and let your MRI team confirm before any scan.

Here's what to do next — you're going to be okay:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.

Don't schedule an MRI based on this page alone — your MRI team verifies every device.

What this means for you

MR Conditional — but the conditions are not yet on file. The label exists. The scan rules (field, SAR, monitoring) do not. Treat as Not determined and let your MRI team confirm before any scan.

Here's what to do next — you're going to be okay:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.
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For information only — your MRI team makes the final decision before any scan. They check every patient, every time.

⚠️

FDA Recall Alert

Class I — Most Serious

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

7/14/2022 · View on FDA.gov

⚠️

FDA Recall Alert

Class I — Most Serious

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

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

7/29/2018 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

5/4/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

5/4/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

5/4/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

5/4/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

5/4/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

5/4/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

5/4/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

5/4/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

5/4/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

5/4/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

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

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

7/29/2018 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

5/4/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

5/4/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

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

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

7/29/2018 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

5/4/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

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

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

7/29/2018 · View on FDA.gov

⚕️ This information is for reference only. A recall does not necessarily mean your device needs removal. Consult your healthcare provider for medical advice.

Regulatory Info

510(k) NumberK172275 ↗
Clearance Date9/26/2017
Product CodeNKB
⚠️2 Active Recalls

Data sourced from openFDA. This is for reference only — consult your healthcare provider for medical advice.

Category

Spinal

Body Region

Spine

MRI Conditions

MRI conditional — verify specific model conditions with manufacturer documentation before scanning.

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Get notified if the FDA issues a recall for this specific implant

Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.