Recall Z-0610-2009 ยท JEY Plate, Bone
Stryker Leibinger USA
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.
| Date | Dec 30, 2008 (initiated Sep 19, 2008) |
| Status | Terminated |
| Reason | A template is supposed to accompany the product, but it was not included with this lot. |
| Root cause | 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 | 23 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014263 | NEWGEN/UNIVERSAL MANDIBULAR SYSTEM Stryker Instruments, Mar 8, 2002 |