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Buckfire & Buckfire, P.C.

Stryker OAYSYS Midline Occiput Plate Recall Lawsuits

Posted on Aug 30, 2013

The Michigan personal injury law firm of Buckfire & Buckfire, P.C. are now actively handling Stryker spine implant recall lawsuits for patients suffering from complications.  The law firm represents patients suffering complications, such as blood loss, nerve injury, or those who have had to undergo a revision surgery due to the defective nature of the Stryker OAYSIS Midline Occiput Plate.

OASYS Midline Occiput Plate is part of the OASYS Occipito-Cervico-Thoracic System used to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput – T3). The OASYS Midline Occiput Plate provides stabilization at the junction between the occipital bone and the vertebrae in the cervical spine.

The OAYSYS device was recently recalled due to reports proving that patients who have had the device were suffering serious injuries and harm resulting from a post-operative fracture of the pin that connects the tulip head to the plate body. Initially, Stryker Orthopaedics did a voluntary recall in May of 2013 warning hospitals and doctors to stop using the affected device and to ship them back to the manufacturer.  However, a month later, in June of 2013, Stryker put out a release warning to all surgeons to conduct post-op evaluations on patients who already have had an OAYSYS implant.

Stryker Orthopaedics is already under some heat right now as thousands of lawsuits are being filed against the manufacturer for their metal-on-metal hip replacements. Both the Stryker Rejuvenate and ABG II implants were recalled last year due to high failure rates and serious complications being suffered by patients.

There are different reported complications a patient is suffering from after having a Stryker OASYS Occipito-Cervico-Thoracic System implanted. Some of the most common complications include:

  • Blood loss
  • Nerve injury
  • Revision surgery

Due to the implant’s association with serious and even deadly complications, the FDA out a Class 1 recall on the OASYS Midline Occiput Plate.  Class 1 recall’s are the FDA’s most serous warning labels.

The affected devices that are being recalled were distributed from April 23, 2010, through February 12, 2013.  The product codes and lot number of those recalled are listed below:

Manufacturing          Part Number                                        Product Description
48551044                OASYS MIDLINE OCCIPUT PLATE,    SMALL
48551045                OASYS MIDLINE OCCIPUT PLATE,    MEDIUM
48551046                OASYS MIDLINE OCCIPUT PLATE,    LARGE
48551047                OASYS MIDLINE OCCIPUT PLATE,    LARGE LONG
48551048                OASYS MIDLINE OCCIPUT PLATE,    MINI

“Patients who suffer from complications or have to undergo a revision surgery due the defective nature of the Stryker OASYS cervical spine implant do have legal rights and should consult with one of our experienced defective medical device lawyers immediately. Due to the fact that the Stryker OASYS Occipito-Cervico-Thoracic System was recalled and have been already implanted into patients, Stryker may be liable for those who do suffer complications. Often times, these lawsuits result in significant settlements, as it seeks damages for pain and suffering, as well as any medical costs incurred and future surgeries if required due to the defective nature of the spine implant,” says Partner and Attorney Lawrence J. Buckfire.

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