Recall Class: Class I
Date Recall Initiated: May 30, 2013
Product: OASYS Midline Occiput Plate
The affected products were distributed from April 23, 2010, through February 12, 2013.
Product Codes and Lot Numbers: KWP; all lots
|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|
Use: The 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.
2 Pearl Court
Allendale, NJ 07401-1611
Reason for Recall:
Stryker has received reports indicating post-operative fracture of the pin that connects the tulip head to the plate body. This may cause serious adverse health consequences including blood loss, nerve injury, and the need for revision surgery to replace the fractured implant.
Public Contact: Questions should be directed to Michelle Barry, Stryker Regulatory Compliance Manager at 201-760-8287 or by email at firstname.lastname@example.org.
FDA District: New Jersey District Office
On May 30, 2013, Stryker issued an Urgent Medical Device Recall requesting medical facilities to examine their inventory and immediately stop distributing or using the recalled lots. If a medical facility has the affected product in stock, it should be returned to Stryker.
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.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or by FAX.