Howmedica Custom Implant System Recalled for Missing Instructions
Howmedica is recalling five custom implant systems because they lacked updated instructions clarifying the locking mechanism and screw warnings.
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, which typically corresponds to a Moderate severity score when no specific injuries or hospitalizations are reported in the source text, and the hazard is primarily related to missing documentation.
Plain-English summary
Howmedica Osteonics Corp. is recalling five units of the Custom Made Implant System with Minimum Invasive Grower (MIG) component. The recall is due to the absence of updated instructions for use (IFU) that clarify the function of the locking mechanism and provide warnings related to the locking screw.
The affected products were manufactured between March 2007 and October 2014. The recall covers units dispatched to New York, Florida, and Kansas. Specific Prosthesis Identification Numbers (PINs) and dispatch dates are listed in the agency record, including PIN 16082 dispatched on April 11, 2011, and PIN 18313 dispatched on December 19, 2013.
This is a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences. Patients who have received these implants should contact their healthcare provider to discuss the missing instructions and any potential risks associated with the locking mechanism.
The recalled product
- Product
- Custom Made Implant System with Minimum Invasive Grower (MIG) component
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 5
Distribution
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