The recall of Stryker Spine’s OASYS Midline Occiput Plate has been deemed a Class I by the U.S. Food and Drug Administration (FDA).
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death.
Agency reports of post-operative device failures involved device fracture, which can lead to serious health consequences such as blood loss, nerve injury, and the need for revision surgery to replace the fractured device. Reports prompted the recall and the FDA’s most serious designation, according to Becker’s Spine Review. The FDA explained that fracture reports involve the pin that connects the implant’s tulip head to the plate body.
Stryker Spine’s OASYS Midline Occiput Plate is part of the OASYS Occipito-Cervico-Thoracic System that is used to urge cervical spine fusion and provide stabilization between the occipital bone and the cervical spine vertebrae, Becker’s Spine Review explained. The United States recall followed a warning by the Australian government earlier this year.
The recalled OASYS Midline Occiput Plate was distributed from April 23, 2010 through February 12, 2013. On May 30, 2013, Stryker issued an Urgent Medical Device Recall requesting medical facilities examine their inventory and immediately stop distributing or using the recalled lots. Medical facilities were advised to return any affected stock to Stryker. Stryker also notified spinal implant surgeons that they should conduct routine clinical and radiographic post-operative evaluation for patients implanted with the recalled OASYS Midline plate. This notification was released on June 20, 2013.
Should a patient experience symptoms such as pain, weakness, or numbness, an urgent evaluation is necessary. Stryker recommends routine post-operative care and follow up for patients who underwent revision surgery to remove and replace the recalled OASYS Midline Occiput Plate.
The recalled OASYS Midline Occiput Plate Product Codes and Lot Numbers: KWP, include all lots and involve the following Manufacturing Part Numbers and Product Descriptions:
- OASYS Midline Occiput Plate, Small; Manufacturing Part Number 48551044
- OASYS Midline Occiput Plate, Medium; Manufacturing Part Number 48551045
- OASYS Midline Occiput Plate, Large; Manufacturing Part Number 48551046
- OASYS Midline Occiput Plate, Large Long; Manufacturing Part Number 48551047
- OASYS Midline Occiput Plate, Mini; Manufacturing Part Number 48551048
Stryker’s Regulatory Compliance Manager, Michelle Barry, can be reached by telephone at 1.201.760.8267 and by email at [email protected].