Z-1239-2018 Class II Terminated
FDA device recall Z-1239-2018 was initiated by Zimmer Biomet, Inc. on Jan 24, 2018 and is designated Class II. Reason for recall: One lot of humeral stem implants do not include the humeral bushing components. The recall status is terminated (terminated Apr 9, 2019). Affected quantity: 9.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 4, 2018
- Initiation Date
- Jan 24, 2018
- Termination Date
- Apr 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9
Product Description
Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
Reason for Recall
One lot of humeral stem implants do not include the humeral bushing components.
Distribution Pattern
Distributed in China and Taiwan.
Code Information
Lot Number: 63694912
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1239-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026