Bone Wax. Ethicon, Inc. Bone wax is available sterile in individual foil envelopes, each containing 2.5 grams, and then
FDA device recall Z-0992-2009 · posted 2009-03-04 · Terminated
Recall details
- Recalling firm
- Ethicon, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- MTJ
- Quantity affected
- 2,200 foil pouches
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-10-28
- Date posted
- 2009-03-04
- Date terminated
- 2009-04-29
- Location
- Somerville, NJ
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