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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Stryker Leibinger USA
Lot Codes / Batch Numbers
Lot J8100F1669.
Products Sold
Lot J8100F1669.
Stryker Leibinger USA is recalling Stryker Leibinger New Generation/Universal Mandibular System, Mand. Recon Plate, Straight, w. Templa due to A template is supposed to accompany the product, but it was not included with this lot.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A template is supposed to accompany the product, but it was not included with this lot.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026