April 18, 2015
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Ortho Solutions releases recall on CIS Plate products

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Ortho Solutions Group recently announced a recall on Coventry Infant System Plate Standard/Heavy Duty/Extra Heavy Duty 130 DEG products, according to a company press release.

The recall was issued due to plate mislabeling. Although the plates were labelled as having an angle of 130°, they were identified as having been manufactured to an angle of 140°.

According to the press release, some of the clinical risks associated with the mislabeling include a low risk that the deformity correction angle achieved would not be clinically acceptable; a risk that the deformity correction angle may be 10° different than the angle planned preoperatively; and, although there have currently been no incidents reported, a low level of risk for patients already implanted with the device.

“We are aware that the accepted surgical practice for using plates of this type is to bend them to achieve the desired correction of the anatomical deformity and assess the correction intraoperatively,” the release stated. “Notwithstanding this accepted surgical practice for checking the correction achieved intraoperatively, using the plate solely as labelled may result in an error in the correction angle achieved.”

The recall closeout date was set as March 6, according to the release.

Reference: www.orthosolutions.com.