FDA Issues Class 1 Recall for Stryker Spine's OASYS Midline Occiput Plate

The U.S. Food and Drug Administration issued a Class 1 recall for Stryker Spine's OASYS Midline Occiput Plate. The agency's most serious recall was initiated after Stryker received reports of post-operative device fractures with the potential to cause blood loss, nerve injury and the need for revision surgery.

The device is part of the OASYS Occipito-Cervico-Thoracic System to promote cervical spine fusion and provide stabilization at the junction between the occipital bone and the cervical spine vertebrae.

The recall comes after the Australian government warned of the device's problems earlier this summer.

Affected products were distributed from April 23, 2010, through Feb. 12.

More Articles on Devices:
Former NASS President Dr. Neil Kahanovitz Wins $2.7M Royalty Dispute With Biomet Subsidiaries
Aurora Spine Opens Expanded California Headquarters
FDA Grants SpineGuard 510(k) Clearance for 3 Versions of PediGuard Platform