Stryker Leibinger New Generation/Universal Mandibular System, Mand. Recon Plate, Straight, w. Template, Stryker Leibinge
FDA device recall Z-0610-2009 · posted 2008-12-30 · Terminated
Recall details
- Recalling firm
- Stryker Leibinger USA
- Reason for recall
- A template is supposed to accompany the product, but it was not included with this lot.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JEY
- Quantity affected
- 23
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-09-19
- Date posted
- 2008-12-30
- Date terminated
- 2009-12-15
- Location
- Portage, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEWGEN/UNIVERSAL MANDIBULAR SYSTEM (K014263) | Stryker Instruments | 2002-03-08 |