Z-0939-2018 Class II Terminated
FDA device recall Z-0939-2018 was initiated by Zimmer Biomet, Inc. on Jan 3, 2018 and is designated Class II. Reason for recall: Two lots of hip implants are mislabeled. The recall status is terminated (terminated Apr 11, 2019). Affected quantity: 24.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 21, 2018
- Initiation Date
- Jan 3, 2018
- Termination Date
- Apr 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24
Product Description
Trabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681)
Reason for Recall
Two lots of hip implants are mislabeled.
Distribution Pattern
Distributed in 2 US states: LA and NY. Distributed in Canada, China, Japan, and Switzerland.
Code Information
Part Numbers: 1. 00-7864-013-00, Lot: 63703649; 2. 00-7864-013-20, Lot: 63703681
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0939-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026