CrossRoads Extremity Systems Recalls MotoBand CP Poly-axial Locking Screws
CrossRoads Extremity Systems is recalling 36 MotoBand CP Poly-axial Locking Screws because they may be the wrong size.
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 dimensional mismatch (wrong size screw) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
CrossRoads Extremity Systems, LLC is recalling 36 units of the MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm. The recall was initiated because the product potentially includes a 3.0mm x 30mm screw instead of the specified 3.0mm x 28mm screw.
The affected screws are identified by Part Number 15PL-3028 and Lot Number 500750. The product was distributed nationwide to Alaska, California, Florida, Georgia, Illinois, Massachusetts, Minnesota, North Carolina, New Jersey, Oklahoma, Oregon, and Washington.
Healthcare professionals and consumers should stop using the affected screws and contact CrossRoads Extremity Systems, LLC for further instructions.
The recalled product
- Product
- MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm
- Manufacturer
- CrossRoads Extremity Systems, LLC
- Hazard
- Affected units
- 36
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 (2)
- Part Number: 15PL-3028
- Lot Number: 500750
Distribution
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