Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated
FDA device recall Z-2284-2013 · posted 2013-09-26 · Terminated
Recall details
- Recalling firm
- Medtronic Xomed, Inc.
- Reason for recall
- One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
- Action taken
- An "URGENT PRODUCT RECALL" letter was faxed to customers following the initial telephone notification. The letter described the product issue and provided recommended actions. Questions were directed to customer service at 800-874-5797.
- Root cause
- Process control
- Status
- Terminated
- Product code
- ETA
- Quantity affected
- 60
- Distribution
- Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
- Date initiated
- 2013-08-23
- Date posted
- 2013-09-26
- Date terminated
- 2013-11-07
- Location
- Jacksonville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TITANIUM MIDDLE EAR PROSTHESES (K002897) | Xomed, Inc. | 2000-10-11 |