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.
Reported: August 28, 2013 Initiated: May 30, 2013 #Z-1976-2013
Product Description
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.
Reason for Recall
Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.
Details
- Recalling Firm
- Stryker Spine
- Units Affected
- 1536 units (US) 880 (Foreign)
- Distribution
- Nationwide Distribution.
- Location
- Allendale, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Stryker Spine. Units affected: 1536 units (US) 880 (Foreign).
Why was this product recalled? ▼
Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2013. Severity: Critical. Recall number: Z-1976-2013.
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