Vitality recallZ-0639-2024 · Zimmer Biomet Spine Inc. · initiated Oct 16, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer Biomet Spine Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On 10/16/23, recall notices were sent to customers asking them to do the following: 1) Locate, quarantine, and return affected screws to the recalling firm. 2) Complete and return the inventory return certificate form via email to [email protected] Recall-related questions or concerns can be directed to please email [email protected].
Recall details
- Recall number
- Z-0639-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 16, 2023
- Posted by the FDA
- Jan 4, 2024
- Recalling firm
- Zimmer Biomet Spine Inc.
- Quantity
- 3
- Product code
- NKB
- FDA submissions
- K150896
- Distribution
- US Nationwide distribution in the states of MN, NE.
Product description
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Code information (models, lots, serial numbers)
UDI-DI: 00889024002159, Lot: W834061
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vitality® 07.02000.118Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease1 recall17 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page