Biomet C-Tek Maxan Anterior Cervical Plate System Mislabeled Recall
Biomet Spine is recalling 7 parts of the C-Tek Maxan Anterior Cervical Plate System because some units were mislabeled with an incorrect part number.
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 FDA Class II, and the hazard is a labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Biomet Spine, LLC is recalling 7 parts of the 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. The affected units are identified by Model Number 14-521614B and Lot Number 375440.
The recall was initiated because some of the units were mislabeled as P/N 14-521614 instead of the correct P/N 14-521614B. This labeling error could lead to the use of the wrong component during a medical procedure.
The affected products were distributed nationwide, including to Ohio, Louisiana, Texas, and Georgia. Healthcare providers and facilities should check their inventory for this specific lot and model number and stop using the affected units.
The recalled product
- Product
- Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.
- Manufacturer
- Biomet Spine, LLC
- Hazard
- Affected units
- 7
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 (2)
- Model Number 14-521614B
- lot number 375440.
Distribution
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