FDA RECALL Stryker Spine - OASYS Midline Occiput Plate
Five lots of Stryker's OASYS Midline Occiput Plate systems were recalled indicating post-operative fracture of the pin that connects the tulip head to the plate body . The devices were used from April 23, 2010 through February 12, 2013.
September 17, 2013 (Newswire.com) - According to the FDA, Stryker has received reports indicating post-operative fracture of the pin that connects the tulip head to the plate body. This may cause adverse health consequences including blood loss, nerve injury, and even the need for revision surgery to replace the fractured implant.
Five lots of Stryker's OASYS Midline Occiput Plate systems were recalled due to this defect. The devices were used from April 23, 2010 through February 12, 2013. Currently, more than 1,500 of the recalled OASYS Midline Occiput Plate units are in circulation in the U.S. The recalled lots are listed below:
Manufacturing Part Number Product Description
1. 48551044 OASYS MIDLINE OCCIPUT PLATE, SMALL
2. 48551045 OASYS MIDLINE OCCIPUT PLATE, MEDIUM
3. 48551046 OASYS MIDLINE OCCIPUT PLATE, LARGE
4. 48551047 OASYS MIDLINE OCCIPUT PLATE, LARGE LONG
5. 48551048 OASYS MIDLINE OCCIPUT PLATE, MINI
The OASYS Midline Occiput Plate is used in spinal fusion surgeries to provide stabilization at the junction between the occipital bone and the vertebrae in the cervical spine. This medical device is part of the complex OASYS Occipito-Cervico-Thoracic System used to promote fusion of the cervical spine and occipito-cervico-thoracic junction.
On June 20, 2013, Stryker notified spinal implant surgeons recommending routine clinical and radiographic post-operative evaluation for patients with an implanted OASYS Midline plate. If a patient begins experiencing symptoms including pain, weakness, or numbness, more urgent evaluation is needed. For patients who have had a revision surgery, Stryker recommends routine post-operative care and follow-up.
If you or a loved one has experienced complications, such as the ones listed above, please contact Keefe Bartels, LLC, immediately by calling 1-877-ATTY-24-7. Attorneys at Keefe Bartels, LLC, are available for free legal consultations to victims of alleged spinal fusion implant failures.
Keefe Bartels, LLC, handles complex medical device implant litigation throughout the nation. The firm's offices are headquartered in Red Bank, New Jersey. For more information, please visit the firm's website www.defectivejoints.com