Device product
OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
Z-1138-2013
Product summary
- Event
- Event 64486
- Status
- Terminated
- Classification
- Class II
- Quantity
- 165
- Official record key
device-enforcement:Z-1138-2013
Official wording
Reason: The firm's retesting procedure was not validated.
Code information: B100164 and B110115
Distribution pattern: USA Nationwide Distribution
Derived failure modes
-
Unknown
The firm's retesting procedure was not validated.