Nextremity Solutions Recalls Stratum Lapidus Plate Due to Labeling Error
Nextremity Solutions is recalling 40 Stratum Lapidus Plate units because the package labeling indicates a right plate, but the product contains a left plate.
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 where the physical product does not match the label. This fits the rubric for moderate severity involving labeling errors without reported injuries.
Plain-English summary
Nextremity Solutions is recalling 40 units of the Stratum Lapidus Plate - Small Rt (Part No. STRM-LAP-SMR, UDI 00817701025467). The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.
The recall was initiated because the product contains a different plate than indicated by the package labeling. Specifically, the product is labeled as a right plate but contains a left plate.
The affected units were distributed domestically to Alabama, California, Florida, Georgia, Idaho, Illinois, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Texas, and Washington. Healthcare providers and patients should verify the specific side of the plate prior to use to ensure the correct implant is utilized.
The recalled product
- Product
- Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.
- Manufacturer
- Nextremity Solutions
- Hazard
- Affected units
- 40
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 M1502
Distribution
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