Z-1543-2020 Class II Terminated
FDA device recall Z-1543-2020 was initiated by Biomet, Inc. on February 17, 2020 and is designated Class II. Reason for recall: A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem. The recall status is terminated (terminated May 31, 2022). Affected quantity: 14 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- February 17, 2020
- Termination Date
- May 31, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
Product Description
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.
Reason for Recall
A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.
Distribution Pattern
International distribution in the countries of Canada, Japan, Netherlands, South Korea.
Code Information
Lot No. 659260, UDI Number: (1)00880304462649(17)290814(10)659260