Stryker Oasys Midline Occiput Plate Recalled for Post-Operative Pin Fracture
Stryker Spine is recalling Oasys Midline Occiput Plates because customer reports indicate post-operative fracture of the pin connecting the tulip head to the plate body.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which mandates a severity score of at least 4 per the rubric, as it involves a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Stryker Spine is recalling the Oasys Midline Occiput Plate, which is available in Small, Medium, Large, Large Long, and Mini sizes. The recall involves 1,536 units distributed in the United States and 880 units distributed in foreign markets. The product is distributed nationwide.
The recall was initiated after Stryker received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body. The affected catalog numbers are 48551044 (Small), 48551045 (Medium), 48551046 (Large), 48551047 (Large Long), and 48551048 (Mini). All lots of these catalog numbers are included in the recall.
This recall is classified as Class I by the FDA. Healthcare providers and patients should contact Stryker Spine for further instructions regarding the affected devices.
The recalled product
- Product
- Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
- Manufacturer
- Stryker Spine
Distribution
Distributed nationwide across the United States.
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