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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Leibinger New Generation/Universal Mandibular System

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  Class 2 Device Recall Stryker Leibinger New Generation/Universal Mandibular System see related information
Date Initiated by Firm September 19, 2008
Date Posted December 30, 2008
Recall Status1 Terminated 3 on December 15, 2009
Recall Number Z-0610-2009
Recall Event ID 50180
510(K)Number K014263  
Product Classification Mandibular Reconstruction Plate - Product Code JEY
Product Stryker Leibinger New Generation/Universal Mandibular System, Mand. Recon Plate, Straight, w. Template, Stryker Leibinger GmbH & Co., Freiburg, Germany; REF # 55-28911.

A mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and reconstruction.
Code Information Lot J8100F1669.
Recalling Firm/
Manufacturer		 Stryker Leibinger USA
750 Trade Center Way Ste 200
Portage MI 49002-0482
For Additional Information Contact
269-323-4226
Manufacturer Reason
for Recall		 A template is supposed to accompany the product, but it was not included with this lot.
FDA Determined
Cause 2		 Process control
Action Consignees were notified via an Urgent Medical Device Recall letter dated September 2008 and requested to examine their inventory for the affected lot and return the recalled product. Customers are to fill out the attached forms to confirm the return-shipment and send it back. The firm will inform customers immediately regarding replacement deliveries.
Quantity in Commerce 23
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 = JEY and Original Applicant = STRYKER INSTRUMENTS
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