Reported Aug 28, 2013 · Terminated

Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly…

Stryker Spine

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Spine · 2 Pearl Ct · Allendale, NJ · 07401-1611

Is this the product you have?

  • 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.
Lot codes and dates
  • K093670 Catalog numbersSmall - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048 All lots of the above
Amount recalled
1536 units (US) 880 (Foreign)

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 30, 2014 · Data as of Sep 19, 6:53 PM UTC

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