FDAFDA · Food and drugs·Recall number Z-1138-2013
OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
Published April 24, 2013 · Recall initiated: February 21, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm's retesting procedure was not validated.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Bacterin International, Inc.
- Distributor
- USA Nationwide Distribution
- Lot
- B100164 and B110115
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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