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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Event Detail

Event ID 65777
Product Type Devices
Status Ongoing
Recalling Firm Stryker Spine
City Allendale
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-30
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. K093670 Catalog numbers: Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048 All lots of the above Class I Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body. 1536 units (US) 880 (Foreign) Z-1976-2013