Biomet Spine Recalls MaxAn Cervical Spine Screws Due to Labeling Error
Biomet Spine is recalling 17 MaxAn cervical spine screws because 4.5 mm units were mislabeled as 4.0 mm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Moderate because it involves a minor labeling error regarding product dimensions, which is a documentation issue rather than a direct contamination or structural defect.
Plain-English summary
Biomet Spine, LLC is recalling 17 units of MaxAn 4.0mm and 4.5mm fixed screws used in the MaxAn Anterior Cervical Plate System. The recall is due to a packaging error where 4.5 mm diameter screws were incorrectly identified and labeled as 4.0 mm diameter screws.
The affected products were distributed in the United States to the states of New York, Missouri, and Florida. The specific lot numbers and part numbers involved are 14-521550 (Lot 463870), 14-521548 (Lot J86056), and 14-521518 (Lot J26394).
Healthcare providers and patients should verify the diameter of the screws against the packaging labels to ensure the correct size is used for cervical spine stabilization procedures.
The recalled product
- Product
- MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.
- Manufacturer
- Biomet Spine, LLC
- Hazard
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- P/N: 14-521550
- Lot Numbers: 463870
- P/N: 14-521548
- Lot Numbers: J86056
- P/N: 14-521518
- Lot Numbers: J26394
- Model Numbers: 14-521518 14-521520 14-521548 14-521550
Distribution
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