Excia Cemented Hip Stems, Size 13mm, Part Number : NJ313K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
FDA Recall Z-0440-2008 · Posted 2007-12-11
Recalling FirmAesculap Implant Systems
Recall StatusTerminated
Product CodeLWJ
Date Initiated2007-10-10
Date Terminated2008-02-07
Product Quantity167 units
Reason for Recall
Sterility (package integrity) Compromised: Device package damaged during shipment
Firm 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.
Root Cause
Package design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.