Crossroads MotoCLIP Super Elastic Fusion System Recalled for Incorrect Sizing
Crossroads Extremity Systems is recalling 20 units of MotoCLIP Super Elastic Fusion Systems because seven implants were incorrectly sized and labeled.
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. The hazard involves a labeling error regarding implant size, which is a significant quality issue but does not explicitly report injuries or hospitalizations in the provided text, fitting the Moderate criteria for labeling errors.
Plain-English summary
Crossroads Extremity Systems LLC is recalling 20 units of the MotoCLIP Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814. The recall involves Lot Number 101868. The product is a prescription-only, sterile medical device.
The recall was initiated because seven 18mm x 18mm x 18mm implants were placed in kits and packed and labeled as 18mm x 14mm x 14mm. This labeling error could result in the use of an incorrectly sized implant.
The affected units were distributed to Alabama, Florida, Indiana, Illinois, Nebraska, Texas, New Mexico, and Colorado. Healthcare providers and patients who have received this specific lot should contact Crossroads Extremity Systems for further instructions.
The recalled product
- Product
- MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
- Manufacturer
- Crossroads Extremity Systems Llc
- Affected units
- 20
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 101868
Distribution
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