FDA Medical Device Recalls (openFDA)
Ethicon, Inc.: 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.
- Recall number
- Z-0992-2009
- 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.
- Status
- Terminated
- Initiated
- 2008-10-28
- Posted
- 2009-03-04
- Terminated
- 2009-04-29
- Reason
- 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
- 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
- 2,200 foil pouches
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MTJ
- Firm FEI
- 2210968
- Firm city
- Somerville
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28