Z-1025-2017 Class II Terminated
FDA device recall Z-1025-2017 was initiated by Zimmer Biomet, Inc. on Dec 19, 2016 and is designated Class II. Reason for recall: Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery. The recall status is terminated (terminated Sep 19, 2017). Affected quantity: 19.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 25, 2017
- Initiation Date
- Dec 19, 2016
- Termination Date
- Sep 19, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19
Product Description
Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
Reason for Recall
Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.
Distribution Pattern
USA (nationwide) and Internationally to ARGENTINA
Code Information
Item XL-200152 Lot 339260 UDI (01)00880304491366(17)210713(10)339260
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1025-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026