Z-1138-2013 Class II Terminated
FDA device recall Z-1138-2013 was initiated by Bacterin International, Inc. on February 21, 2013 and is designated Class II. Reason for recall: The firm's retesting procedure was not validated. The recall status is terminated (terminated July 1, 2013). Affected quantity: 165.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2013
- Initiation Date
- February 21, 2013
- Termination Date
- July 1, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 165
Product Description
OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
Reason for Recall
The firm's retesting procedure was not validated.
Distribution Pattern
USA Nationwide Distribution
Code Information
B100164 and B110115