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U.S. Department of Health and Human Services

Class 2 Device Recall Bone Wax

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 Class 2 Device Recall Bone Waxsee related information
Date Initiated by FirmOctober 28, 2008
Date PostedMarch 04, 2009
Recall Status1 Terminated 3 on April 29, 2009
Recall NumberZ-0992-2009
Recall Event ID 50132
Product Classification Bone Wax - Product Code MTJ
ProductBone 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Ethicon, Inc.
US Highway 22 West
Somerville NJ 08876
For Additional Information ContactChristiana Bielinski
908-218-2553
Manufacturer 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.
FDA Determined
Cause 2		Process design
ActionLetters 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 Commerce2,200 foil pouches
DistributionNationwide Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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