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.
FDA Recall Z-0610-2009 · Posted 2008-12-30
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Recalling FirmStryker Leibinger USA
Recall StatusTerminated
Product CodeJEY
Date Initiated2008-09-19
Date Terminated2009-12-15
Product Quantity23
Reason for Recall
A template is supposed to accompany the product, but it was not included with this lot.
Firm 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.
Root Cause
Process control
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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