Device product
MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with T-Handle Trial Spacer 17mm with T-Handle
Z-0349-2020
Product summary
- Event
- Event 83991
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 units
- Official record key
device-enforcement:Z-0349-2020
Official wording
Reason: Modified outside of approved manufacturing process
Code information: Unknown
Distribution pattern: AR
Derived failure modes
-
Unknown
Modified outside of approved manufacturing process