Z-0517-2020 Class II Terminated
FDA device recall Z-0517-2020 was initiated by Zimmer Biomet, Inc. on August 6, 2019 and is designated Class II. Reason for recall: The potential that the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument, part number 110032331. The recall status is terminated (terminated August 24, 2020). Affected quantity: 73.
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2019
- Initiation Date
- August 6, 2019
- Termination Date
- August 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 73
Product Description
ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, Model Number 110032331
Reason for Recall
The potential that the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument, part number 110032331.
Distribution Pattern
CA, IN, MN, NJ, NY, AR, LA, OH, KY, TX, CO (US) CA, CN, NL (International)
Code Information
Model Number: 11032331 Lots: 784060, 662870