Ethicon, Inc. US 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Ethicon, Inc. US
Lot Codes / Batch Numbers
Product code: W31
Products Sold
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.
Ethicon, Inc. US is recalling Bone Wax. Ethicon, Inc. Bone wax is available sterile in individual foil envelopes, each containi due to 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 recei. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026