Recall Z-0441-2008 ยท LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Aesculap Implant Systems
Excia Cemented Hip Stems, Size 14mm, Part Number : NJ314K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
| Date | Dec 11, 2007 (initiated Oct 10, 2007) |
| Status | Terminated |
| Reason | Sterility (package integrity) Compromised: Device package damaged during shipment |
| Root cause | Package design/selection |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042344 | EXCIA TOTAL HIP SYSTEM Aesculap, Inc., Mar 16, 2005 |