In August 2013, the FDA and Stryker announced a Class 1 recall of the OASYS Midline Occipital Plate, a spine plate used in cervical spinal fusion surgery. The company has received post-operative reports of fracture of a pin that connects the tulip head to the plate body. Stryker recommends urgent treatment for patients with symptoms, including pain, weakness, or numbness.
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Stryker Orthopedics manufactures the OASYS Midline Occiput Plate, a part of the OASYS Occipito-Cervico-Thoracic System. The products are used in spinal fusion surgery in the cervical (neck) and thoracic (upper-back) regions. The product is used to stabilize bones while they fuse together.
FDA Safety Alert for Stryker Spine Plate
According to the Stryker spine plate recall notice, the recall was initiated due to the following problem:
“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.”
Timeline of Stryker Spine Plate Recall
- April 2010 – February 2013 — Stryker OASYS spine plate sold in the U.S.
- May 30, 2013 — Stryker began the spine plate recall on May 30, when they issued an “Urgent Medical Device Recall” to recommend that medical facilities and surgeons should immediately stop using the product.
- June 20, 2013 — Stryker recommended routine clinical and radiographic imaging for patients implanted with the OASYS Midline Plate.
- July 22, 2013 — The Australian Stryker Spine Plate Hazard Alert was published.
- August 30, 2013 — The FDA Stryker Spine Plate Recall is announced.
What products were recalled?
Manufacturing codes and products in Stryker spine plate recall:
- 48551048 – OASYS MIDLINE OCCIPUT PLATE, MINI
- 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
Need a Stryker Spine Plate Lawyer in Texas?
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