Z-0445-2008

Excia Cemented Hip Stems ,Size 18mm, Part Number NJ318K, Aesculap Implant Systems, Inc., Center Valley, PA...

Name: Z-0445-2008 Excia Cemented Hip Stems ,Size 18mm, Part Number NJ318K, Aesculap Implant Systems, Inc., Center Valley, PA...
Creator: Aesculap Implant Systems
Published: 2007-10-10
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2007-10-10 / Terminated / root cause: packaging

FDA source

Aesculap Implant Systems began a recall of Excia Cemented Hip Stems ,Size 18mm, Part Number NJ318K, Aesculap Implant Systems, Inc., Center Valley, PA 18034 on 2007-10-10. The reason FDA records is "Sterility (package integrity) Compromised: Device package damaged during shipment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0445-2008
Status: Terminated
Initiated: 2007-10-10
Posted: 2007-12-11
Terminated: 2008-02-07
Recalling firm: Aesculap Inc
Product: Excia Cemented Hip Stems ,Size 18mm, Part Number NJ318K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
Product code: LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Reason for recall: Sterility (package integrity) Compromised: Device package damaged during shipment
Root cause tag: packaging
FDA 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 in commerce: 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.
Product codes and lots: All Lot Numbers

Product code LWJ

K042344Class IIExcia Total Hip SystemAesculap, Inc. / cleared 2005-03-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)