Stryker Leibinger New Generation/Universal Mandibular… recallZ-0610-2009 · Stryker Leibinger USA · initiated Sep 19, 2008
Terminated All recalls posted in December 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Leibinger USA or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A template is supposed to accompany the product, but it was not included with this lot.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0610-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 19, 2008
- Posted by the FDA
- Dec 30, 2008
- Recalling firm
- Stryker Leibinger USA
- Quantity
- 23
- Product code
- JEY
- FDA submissions
- K014263
- Distribution
- Nationwide Distribution
Product 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.
Code information (models, lots, serial numbers)
Lot J8100F1669.
Other devices under the same FDA submission
5 devices cleared under K014263 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 55-28922Stryker Leibinger GmbH & Co. KG · PLATE, BONE2 reports
- SMARTLOCK 52-20504Stryker Leibinger GmbH & Co. KG · PLATE, BONE2 reports
- NA 52-20405Stryker Leibinger GmbH & Co. KG · PLATE, BONE2 reports
- NA 52-20404Stryker Leibinger GmbH & Co. KG · PLATE, BONE1 report
- SMARTLOCK 52-20505Stryker Leibinger GmbH & Co. KG · PLATE, BONE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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