Z-0992-2009

Bone Wax. Ethicon, Inc. Bone wax is available sterile in individual foil envelopes, each containing 2.5...

Name: Z-0992-2009 Bone Wax. Ethicon, Inc. Bone wax is available sterile in individual foil envelopes, each containing 2.5...
Creator: Ethicon, Inc.
Published: 2008-10-28
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2008-10-28 / Terminated / root cause: manufacturing process

FDA source

Ethicon, Inc. began a recall of 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... on 2008-10-28. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0992-2009
Status: Terminated
Initiated: 2008-10-28
Posted: 2009-03-04
Terminated: 2009-04-29
Recalling firm: Ethicon, Inc
Product: 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.
Product code: MTJ Wax, Bone
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.
Root cause tag: manufacturing process
FDA root cause: Process design
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.
Quantity in commerce: 2,200 foil pouches
Distribution: Nationwide Distribution.
Product codes and lots: Product code: W31; Lot # AG089. W31 is the product code for unfinished product. AG089 is the lot number assigned by Sharp Corp. DW31B is assigned on the inner box labels.

Product code MTJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)