K2M Special Connector Instruments Recalled for Regulatory Filing Deficiencies
K2M, Inc. is recalling 503 Special Connector Instruments because they were developed without adequate consideration for a new regulatory filing.
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, but the source text identifies the issue as a regulatory filing deficiency rather than a direct physical hazard or reported injury, aligning with the 'Moderate' criteria for minor or procedural issues.
Plain-English summary
K2M, Inc. is recalling 503 units of Special Connector Instruments, including Special Connectors, Special Adaptors, and Quick Adaptors. These instruments are designed to allow surgeon users to combine them with non-K2M navigation systems as part of their standard surgical technique. The recall covers all product lots in distribution as of December 1, 2016.
The recall was initiated because the instruments were developed without adequate consideration given to the need for a new regulatory filing. This event was reported to the FDA as part of Stryker's retrospective review of K2M product field actions. The recall actions were completed in 2017.
The products were distributed nationwide in the states of Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Pennsylvania, Tennessee, Texas, Utah, and Virginia. Consumers and healthcare providers should stop using these instruments and contact the recalling firm for further instructions.
The recalled product
- Product
- K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instruments include an additional feature on their shafts that enable surgeon users to combine them with non-K2M navigation systems as part of their…
- Manufacturer
- K2M, Inc
- Affected units
- 503
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 (3)
- All product lots in distribution as of December 1
- 2016
- are in scope.
Distribution
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