FDA-Device2013-08-28Class I
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.
Stryker Spine
Hazard
Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.
Sold states
Nationwide Distribution.
Affected count
1536 units (US) 880 (Foreign)
Manufactured in
2 Pearl Ct, N/A, Allendale, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1976-2013Don't want to check this manually?
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