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U.S. Department of Health and Human Services

Class 1 Device Recall Stryker Spine Oasys Midline Occiput Plate

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  Class 1 Device Recall Stryker Spine Oasys Midline Occiput Plate see related information
Date Initiated by Firm May 30, 2013
Date Posted August 22, 2013
Recall Status1 Terminated 3 on December 30, 2014
Recall Number Z-1976-2013
Recall Event ID 65777
510(K)Number K093670  
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
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.
Code Information K093670   Catalog numbers:  Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048  All lots of the above
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Mr. Timothy Huntington
201-831-5556
Manufacturer 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 1536 units (US) 880 (Foreign)
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWP and Original Applicant = STRYKER SPINE
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