Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW SYSTEM, HUMERAL CONDYLE SET - HEXALOBULAR, CO-CR-MO / YI-GAL-4V
FDA device recall Z-2660-2011 · posted 2011-06-24 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The firm initiated this recall after becoming aware that a Discovery Condyle Kit with Hexalobula contained two male condyles instead of a male and female condyle.
- Action taken
- Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated May 25, 2011 to all affected customers. The notice describes the product, problem, and actions to be taken by the customers. The notice instructed customers to locate and remove the product. Customers were asked to complete a response form and fax to 574-372-1683, within 3 business days. Additionally, customers were instructed to ship the package priority mail with a copy of the response form. Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday 8 AM to 5 PM.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- JDC
- Quantity affected
- 10 KITS
- Distribution
- Worldwide Distribution--USA (nationwide) including the states of AR and SD and the country of Japan.
- Date initiated
- 2011-04-29
- Date posted
- 2011-06-24
- Date terminated
- 2011-08-29
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POROUS COATED DISCOVERY ELBOW (K051975) | Biomet, Inc. | 2005-09-06 |