Z-1024-2017 Class II Terminated
FDA device recall Z-1024-2017 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: 36.
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
- 36
Product Description
RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223
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-108323 Lot 761680 UDI (01)00880304651524(17)210713(10)761680 Item XL-108223 Lot 419460 UDI (01)00880304651494(17)210713(10)419460
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1024-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026