CLASS II Device recall · Reported 14 Jun 2017 · FDA Enforcement Report
Vitality Spinal Fixation System recalled by Zimmer Biomet Spine
Zimmer Biomet Spine is recalling Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting, distributed nationwide in the US. The recall was initiated on 10 May 2017 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-2318-2017
- FDA event ID
- 77251
- Recalling firm
- Zimmer Biomet Spine, Westminster, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 May 2017
- FDA classified
- 8 Jun 2017
- Reported
- 14 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Spinal Implants
Timeline
| 10 May 2017 | Recall initiated by company | |
| 8 Jun 2017 | Classified by FDA | +29 days |
| 14 Jun 2017 | 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
Zimmer Biomet is conducting a medical device recall for Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs because when applying torque to tighten the closure top the driver has the potential to create a torsional spring which can cause damage and the potential for the values of torque to go out of specification.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017
Where it was distributed
Nationwide, military/VA/govt and foreign consignee (No Canadian consignees)
Questions about this recall
Why was it recalled?
Zimmer Biomet is conducting a medical device recall for Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs because when applying torque to tighten the closure top the driver has the potential to create a torsional spring which can cause damage and the potential for the values of torque to go out of specification.
Which lots are affected?
Model No: 07.02066.001 (All lots); 07.02053.001 (All lots distributed prior to April 26, 2017), and 730M0017 (Lot 309622)
Where was it sold?
Nationwide, military/VA/govt and foreign consignee (No Canadian consignees)
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zimmer Biomet Spine
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Vitality Polyaxial Screw, 7.5mmx recalled by Zimmer Biomet Spine | Zimmer Biomet Spine | Packaging Defects | Nationwide |
| Device | CLASS II | Vitality¿ Spinal Fixation System recalled by Zimmer Biomet Spine | Zimmer Biomet Spine | Other | Nationwide |
| Device | CLASS II | Vitality¿ Spinal Fixation System recalled by Zimmer Biomet Spine | Zimmer Biomet Spine | Other | Nationwide |
| Device | CLASS II | Vitality¿ Spinal Fixation System.Spinal Intervertebral recalled | Zimmer Biomet Spine | Other | Nationwide |
| Device | CLASS II | Altius M-ini OCT Posterior Spinal Fixation System recalled | Zimmer Biomet Spine | Potency & Assay | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |