FDA-Device2017-01-25Class II
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
Zimmer Biomet, Inc.
Hazard
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.
Sold states
USA (nationwide) and Internationally to ARGENTINA
Affected count
36
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1024-2017Don't want to check this manually?
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