MicroPort Profemur Modular Neck Recalled for Labeling Error
MicroPort Orthopedics is recalling 14 units of Profemur Modular Necks due to a labeling error where item numbers were incorrectly assigned.
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 involves a labeling error (mis-labeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
MicroPort Orthopedics Inc. is recalling 14 units of the PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK (Item Number PHA01222, Short AR VV2 Ti Neck). The recall was initiated because these specific units were incorrectly labeled as Item Number PHA01212 (Short AR VV1 Ti Neck). The affected lot number is 1645222.
The product is intended for use in total hip arthroplasty for the reduction or relief of pain and/or improved hip function in skeletally mature patients. The distribution of the affected units was limited to Belgium, Italy, Spain, and Poland.
This is an FDA Class II recall. No specific instructions for consumers are provided in the source text, but the error involves the identification of the specific component variant.
The recalled product
- Product
- PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
- Manufacturer
- MicroPort Orthopedics Inc.
- Hazard
- Affected units
- 14
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)
- Lot number 1645222
Distribution
Distribution scope not specified by the agency.
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