Device product
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
Z-1467-2023
Product summary
- Event
- Event 92078
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 50 units
- Official record key
device-enforcement:Z-1467-2023
Official wording
Reason: Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
Code information: UDI/DI 00889797101035, Lot Number 1737413
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.