Foundation Tibia Baseplate, Catalog number 324-01-108. The tibial is modular in design, such that plastic inserts of var
FDA device recall Z-0622-2010 · posted 2010-01-13 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Product does not meet specifications for a size 8 Right Foundation Tibia Baseplate.
- Action taken
- Firm notified consignees by an Urgent Field Safety Notice dated 12/3/2009. The letter identified the product, stated the problem, and the risk associated with the problem. Customers are to immediately return the affected product and notify all of their customers if product was further distributed. Customers are to complete and return the enclosed response form. Questions should be directed to David Harris, Manager of Customer Service at 512-834-6330 or Valerie Moulton, International Customer Service at 512-834-6275.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 17
- Distribution
- Worldwide Distribution -- USA, including states of GA, OK, FL, CA, and SD, and countries of Germany and Turkey.
- Date initiated
- 2009-12-03
- Date posted
- 2010-01-13
- Date terminated
- 2010-05-05
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FOUNDATION MODULAR TIBIAL BASEPLATE (K932425) | Encore Orthopedics, Inc. | 1994-07-22 |