CLASS II ONGOING Device recall · Reported 10 Jan 2024 · FDA Enforcement Report
Vitality Polyaxial Screw, 5mmx recalled by Zimmer Biomet Spine
Zimmer Biomet Spine is recalling Vitality Polyaxial Screw, 5mmx, distributed nationwide in the US. The recall was initiated on 16 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0639-2024
- FDA event ID
- 93650
- Recalling firm
- Zimmer Biomet Spine, Westminster, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Oct 2023
- FDA classified
- 4 Jan 2024
- Reported
- 10 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Spinal Implants
Timeline
| 16 Oct 2023 | Recall initiated by company | |
| 4 Jan 2024 | Classified by FDA | +80 days |
| 10 Jan 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Where it was distributed
US Nationwide distribution in the states of MN, NE.
Questions about this recall
Is Vitality Polyaxial Screw, 5mmx recalled?
Yes. Zimmer Biomet Spine recalled Vitality Polyaxial Screw, 5mmx on 16 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-0639-2024.
Why was it recalled?
Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures.
Which lots are affected?
UDI-DI: 00889024002159, Lot: W834061
Where was it sold?
US Nationwide distribution in the states of MN, NE.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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