Excia Cemented Hip Stems, Size 13mm, Part Number : NJ313K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
FDA device recall Z-0440-2008 · posted 2007-12-11 · Terminated
Recall details
- Recalling firm
- Aesculap Implant Systems
- Reason for recall
- Sterility (package integrity) Compromised: Device package damaged during shipment
- Action taken
- The recalling firm issued an Important Recall Notice letter dated 10/10/07 to all their customers informing them of the problem and the need to return the product.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- LWJ
- Quantity affected
- 167 units
- Distribution
- Nationwide-USA including states of AZ, GA, MD, OK, PA, TX, and VA (distributors) medical facilities in FL, NY, and PA; and sales representatives in CA and FL.
- Date initiated
- 2007-10-10
- Date posted
- 2007-12-11
- Date terminated
- 2008-02-07
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXCIA TOTAL HIP SYSTEM (K042344) | Aesculap, Inc. | 2005-03-16 |