Recall Z-1976-2013— Stryker Spine

Name: FDA recall Z-1976-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-30

Class I · Terminated

Class I FDA medical device recall by Stryker Spine, initiated 2013-05-30, terminated 2014-12-30. It names one FDA 510(k) clearance: K093670. 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.. Reason: Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body..

Recalling firm: Stryker Spine
Classification: Class I
Status: Terminated
Initiated: 2013-05-30
Terminated: 2014-12-30
Firm location: Allendale, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K093670 — MODIFICATION TO: OASYS SYSTEMStryker Spine·cleared 2010-03-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.