Recall Z-0436-2008
Aesculap Implant Systems · initiated October 10, 2007
Product
Excia Cemented Hip Stems, Size 9mm, Part Number: NJ309K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
Codes / lots: All Lot Numbers
Reason for recall
Sterility (package integrity) Compromised: Device package damaged during shipment
FDA-determined cause: Package design/selection
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.
Details
- Recall number
- Z-0436-2008
- Initiated
- October 10, 2007
- Posted by FDA
- December 11, 2007
- Terminated
- February 7, 2008
- Product code
- LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- 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.
- Recalling firm
- Aesculap Implant Systems, Center Valley, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0437-2008 | Excia Cemented Hip Stems, Size 10mm, Part Number: NJ310K, Aesculap Implant Systems…Sterility (package integrity) Compromised: Device package damaged during shipment | 10/10/2007Terminated |
| Z-0438-2008 | Excia Cemented Hip Stems, Size 11mm, Part Number : NJ311K, Aesculap Implant Systems…Sterility (package integrity) Compromised: Device package damaged during shipment | 10/10/2007Terminated |
| Z-0439-2008 | Excia Cemented Hip Stems, Size 12mm, Part Number: NJ312K, Aesculap Implant Systems…Sterility (package integrity) Compromised: Device package damaged during shipment | 10/10/2007Terminated |
| Z-0440-2008 | Excia Cemented Hip Stems, Size 13mm, Part Number : NJ313K, Aesculap Implant Systems…Sterility (package integrity) Compromised: Device package damaged during shipment | 10/10/2007Terminated |
| Z-0441-2008 | Excia Cemented Hip Stems, Size 14mm, Part Number : NJ314K, Aesculap Implant Systems…Sterility (package integrity) Compromised: Device package damaged during shipment | 10/10/2007Terminated |
| Z-0442-2008 | Excia Cemented Hip Stems, Size 15mm, Part Number: NJ315K Aesculap Implant Systems, Inc.…Sterility (package integrity) Compromised: Device package damaged during shipment | 10/10/2007Terminated |
| Z-0443-2008 | Excia Cemented Hip Stems, Size 16mm, Part Number NJ316K, Aesculap Implant Systems, Inc.…Sterility (package integrity) Compromised: Device package damaged during shipment | 10/10/2007Terminated |
| Z-0444-2008 | Excia Cemented Hip Stems, Size 17mm, Part Number : NJ317K, Aesculap Implant Systems…Sterility (package integrity) Compromised: Device package damaged during shipment | 10/10/2007Terminated |
| Z-0445-2008 | Excia Cemented Hip Stems ,Size 18mm, Part Number NJ318K, Aesculap Implant Systems, Inc.…Sterility (package integrity) Compromised: Device package damaged during shipment | 10/10/2007Terminated |