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Terminated

Excia Cemented Hip Stems, Size 15mm, Part Number: NJ315K Aesculap Implant Systems, Inc., Center Valley, PA 18034

FDA Recall Z-0442-2008 · 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.

K042344EXCIA TOTAL HIP SYSTEMAesculap, Inc. · 2005-03-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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