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Stryker initiates class I recall and Australian hazard alert for occipital plate

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Stryker has announced a class I recall for its Oasys Midline Occiput Plate used in cervical spine fusion surgery following reports of postoperative fracture of the pin that connects the tulip head to the plate body, which may destabilize the plate and cause patients to need revision surgery. The Australian Department of Health and Ageing Therapeutic Goods Association has also partnered with Stryker Australia to announce a hazard alert for the plate.

“In February 2013, Stryker Spine instructed all US registered Oasys System surgeon users to discontinue use and ordering of the Oasys Midline Occiput Plate and in May 2013 voluntarily recalled the product,” Joe Cooper, director of global communications at Stryker, told Orthopedics Today. “These actions were taken after Stryker received reports of a fracture of the pin on the midline plate. This issue was identified through standard post-market surveillance of product complaints. A Product Notification was issued to surgeons and hospital risk managers which described the known hazards and harms potentially associated with the use of the affected products.”

According to the Therapeutic Goods Association hazard alert, the cause of the problem is currently unknown and the manufacturer is investigating cases from the US and Belgium. No cases of the problem had been reported in Australia at the time of the hazard alert.

The Oasys Midline Occiput Plate is part of the Oasys Occipito-Cervico-Thoracic System used for fusion of the cervical spine at the occipito-cervico-thoracic junction, between occiput and T3, according to the FDA release. When using the system, stabilization occurs at the junction and between the occipital bone and the vertebrae in the cervical spine.

The products affected by the recall were produced between April 23, 2010 and Feb. 12, 2013. Surgeons still in possession of the plates should discontinue use and return the products to Stryker.

“As stated in the February 2013 Product Notification, Stryker recommended that patient follow-up beyond the routine standard of care was not necessary,” Cooper said.

To see the list of recalled parts, click here.

Reference:

www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm366713.htm

www.tga.gov.au/safety/alerts-device-oasys-midline-plate-130722.htm