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.
Recall
- Recall Number
- Z-0610-2009
- Event Number
- 50180
- Firm
- Stryker Leibinger USA
- FEI Number
- 3005101424
- Product Code
- JEY
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- September 19, 2008
- Posted
- December 30, 2008
- Terminated
- December 15, 2009
- Address
- 750 Trade Center Way, Ste 200, Portage, MI, 49002-0482
Description
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.
A template is supposed to accompany the product, but it was not included with this lot.
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.
Nationwide Distribution
23