Biomet Spine Lineum OCC Starter Flexible Instruments Recalled for Design Control Issues
Biomet Spine is recalling Lineum OCC Starter Flexible instruments because they were distributed before design control activities were completed.
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 source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Biomet Spine, LLC is recalling 49 units of the Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft instruments, model numbers 14-525050 and 14-525057. These reusable medical devices are used in the Lineum system for cervical and upper thoracic spine reconstruction.
The recall was initiated because the instruments were distributed prior to the completion of all required design control activities. The affected units were distributed worldwide, including in the United States (New York, Missouri, Wisconsin, Indiana, California, North Carolina, and Ohio) and in Japan and the Netherlands.
Healthcare facilities and consumers should stop using these specific instruments immediately. Biomet Spine is the recalling firm and is responsible for managing the recall process.
The recalled product
- Product
- Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic…
- Manufacturer
- Biomet Spine, LLC
- Affected units
- 49
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 (1)
- P/N 14-525050 Lot Number 001219 P/N 14-525057 Lot Number 001220
Distribution
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