Z-1000-2020 Class II Terminated
FDA device recall Z-1000-2020 was initiated by Zimmer Biomet, Inc. on December 12, 2019 and is designated Class II. Reason for recall: The lot contained two outer pins instead of one outer and one inner pin. The recall status is terminated (terminated January 13, 2021). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- December 12, 2019
- Termination Date
- January 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained cemented prosthesis.
Reason for Recall
The lot contained two outer pins instead of one outer and one inner pin.
Distribution Pattern
Distributed to accounts in California and Ohio.
Code Information
Lot 64481139