Z-0610-2009

Stryker Leibinger New Generation/Universal Mandibular System, Mand. Recon Plate, Straight, w. Template...

Name: Z-0610-2009 Stryker Leibinger New Generation/Universal Mandibular System, Mand. Recon Plate, Straight, w. Template...
Creator: Stryker Leibinger USA
Published: 2008-09-19
License: https://open.fda.gov/license/

Stryker Craniomaxillofacial Division / initiated 2008-09-19 / Terminated / root cause: manufacturing process

FDA source

Stryker Leibinger USA began a recall of Stryker Leibinger New Generation/Universal Mandibular System, Mand. Recon Plate, Straight, w. Template, Stryker Leibinger GmbH & Co., Freiburg, Germany; REF #... on 2008-09-19. The reason FDA records is "A template is supposed to accompany the product, but it was not included with this lot". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0610-2009
Status: Terminated
Initiated: 2008-09-19
Posted: 2008-12-30
Terminated: 2009-12-15
Recalling firm: Stryker Craniomaxillofacial Division
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.
Product code: JEY Plate, Bone
Reason for recall: A template is supposed to accompany the product, but it was not included with this lot.
Root cause tag: manufacturing process
FDA 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 in commerce: 23
Distribution: Nationwide Distribution
Product codes and lots: Lot J8100F1669.

Product code JEY

K014263Class IINewgen/universal Mandibular SystemStryker Instruments / cleared 2002-03-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)