Device product
SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
Z-0585-2016
Product summary
- Event
- Event 72774
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65
- Official record key
device-enforcement:Z-0585-2016
Official wording
Reason: The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.
Code information: Part number: 352.135; Lot number: F-17180
Distribution pattern: US nationwide distibution.
Derived failure modes
-
Unknown
The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.