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.
FDA Recall Z-1976-2013 · Posted 2013-08-22
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Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeKWP
Date Initiated2013-05-30
Date Terminated2014-12-30
Product Quantity1536 units (US) 880 (Foreign)
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.
Firm Action
Stryker Spine sent a 'Urgent Medical Device Removal Letter'/'Customer Response Form' to Branch Managers, Agent Principals, Quality Contacts, Hospital OR Risk Managers, OR supervisor on 5/30/2013 via Fed Ex. Inventory should be examined and returned.The attached form should be completed and returned as well.
Stryker Spine sent 'Urgent Medical Device Removal Letters' to Spinal Implant Surgeons on 6/20/2013 via Fed Ex.
Root Cause
Other
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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