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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Product Detail

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.
Recall Number Z-1976-2013
Classification Class I
Code Info K093670 Catalog numbers: Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048 All lots of the above
Product Distributed Qty 1536 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.

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 Letter
Distribution Pattern Nationwide Distribution.