Device product
Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.
Z-1543-2020
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 85073
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 units
- Official record key
device-enforcement:Z-1543-2020
Official wording
Reason: A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.
Code information: Lot No. 659260, UDI Number: (1)00880304462649(17)290814(10)659260
Distribution pattern: International distribution in the countries of Canada, Japan, Netherlands, South Korea.
Derived failure modes
-
Unknown
A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.