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.
This recall has been terminated (originally issued December 30, 2008).
- Company
- Stryker Leibinger Usa
- Recall Initiated
- September 19, 2008
- Posted
- December 30, 2008
- Terminated
- December 15, 2009
- Recall Number
- Z-0610-2009
- Quantity
- 23
- Firm Location
- Portage, MI
- Official Source
- View on FDA website ↗
Reason for Recall
A template is supposed to accompany the product, but it was not included with this lot.
Distribution
Nationwide Distribution
Lot / Code Info
Lot J8100F1669.
Root Cause
Process control
Action Taken
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.