FDA Medical Device Recalls (openFDA)
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 number
- Z-0610-2009
- Recalling firm
- Stryker Leibinger USA
- 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.
- Status
- Terminated
- Initiated
- 2008-09-19
- Posted
- 2008-12-30
- Terminated
- 2009-12-15
- 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
- Lot, serial or model codes
- Lot J8100F1669.
- 510(k) numbers
- ["K014263"]
- PMA numbers
- not on file
- Product code
- JEY
- Firm FEI
- 3005101424
- Firm city
- Portage
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28