FDA Device recall Z-0868-2019
Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile)
- FDA Device
- Class II
- terminated
- Published 2019-03-06
On 2019-03-06 the FDA classified a Class II recall of Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile) by Zimmer Biomet Spine, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0868-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-30 |
| Published | 2019-03-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet Spine |
| Distribution | US |
Product
Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: 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
Reason
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
Identifiers
| code_info | Item Number; Lot Number; Item Description; UDI #; Manufacturing Quantity 07.02011.001; P141352 (Z00176603); Vitalit…Item Number; Lot Number; Item Description; UDI #; Manufacturing Quantity 07.02011.001; P141352 (Z00176603); Vitality Shear-off Set Screw; (01)00889024003187 (10)P141352; 2,192 devices 07.02011.001; P141353; Vitality Shear-off Set Screw; (01)00889024003187 (10)P141353; 879 devices 07.02011.001; P141354 (Z00468651); Vitality Shear-off Set Screw; (01) 00889024003187 (10)P141354; 924 devices 07.02011.001; P141358 (Z00420148); Vitality Shear-off Set Screw; (01)00889024003187 (10)P141358; 2,193 devices 07.02011.001; P141359 (Z00274115); Vitality Shear-off Set Screw; (01)00889024003187 (10)P141359; 868 devices 07.02011.001; P141360; Vitality Shear-off Set Screw; (01)00889024003187 (10)P141360; 872 devices 07.02011.001; P142510; Vitality Shear-off Set Screw; (01)00889024003187 (10)P142510; 3,045 devices 07.02011.001; W505611; Vitality Shear-off Set Screw; (01)00889024003187 (10)W505611; 1,545 devices 07.02011.001; W508041; Vitality Shear-off Set Screw; (01)008 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0868-2019%22
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