Device product
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
Z-1256-2018
Product summary
- Event
- Event 79241
- Status
- Completed
- Classification
- Class II
- Quantity
- 92 units
- Official record key
device-enforcement:Z-1256-2018
Official wording
Reason: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants
Code information: All Serial Numbers
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants