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Terminated

Bone Wax. Ethicon, Inc. Bone wax is available sterile in individual foil envelopes, each containing 2.5 grams, and then packaged in an individually sealed over wrap packet. The device is indicated for use to control bleeding from the bone surface during surgical procedures.

FDA Recall Z-0992-2009 · Posted 2009-03-04

Recalling FirmEthicon, Inc.
Recall StatusTerminated
Product CodeMTJ
Date Initiated2008-10-28
Date Terminated2009-04-29
Product Quantity2,200 foil pouches

Reason for Recall

A hospital reported to their Ethicon sales representative that they had an "unmarked" box of bone was on their shipping dock that they could not receive due to lack of appropriate documentation. Upon investigation, this box was determined to be missing from a shipment between two steps of the manufacturing process. Further checks determined that two other boxes were missing.

Firm Action

Letters were sent via UPS next day air on October 28, 2008 to all customers who purchased finished product codes W31G and DW31B (on inner box labels) from January 1, 2008 through October 22, 2008.

Root Cause

Process design

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

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

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