Nextremity Solutions Recalls Stratum Foot Plating System Screws Due to Incorrect Specifications
Nextremity Solutions is recalling 49 units of Stratum Foot Plating System screws because they may contain the incorrect screw type and length.
What this means for you
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 injuries, illnesses, or deaths. The hazard is a potential specification error (incorrect type/length) without reported adverse events, fitting the criteria for a moderate severity score.
Plain-English summary
Nextremity Solutions is recalling 49 units of the Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. The affected products are identified by Catalog Number STRM-NL-3550ST and Lot Number M1151. These medical devices are indicated for the fixation of fractures, osteotomies, nonunions, malunions, and fusions of small bones and small bone segments, particularly in osteopenic bone.
The recall was initiated because the product may contain the incorrect screw type and length. The source text does not specify the exact nature of the discrepancy or report any associated injuries or illnesses. The affected units were distributed nationwide in the United States.
Healthcare providers and facilities should stop using the affected lots and contact Nextremity Solutions for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and sma
- Manufacturer
- Nextremity Solutions
- Hazard
- 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)
- Lot Number: M1151 UDI: 00817701022558
Distribution
Distributed nationwide across the United States.
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