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Recall Observatory FDA recall evidence

Device product

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

Z-1024-2017

December 19, 2016

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 75970
Status
Terminated
Classification
Class II
Quantity
36
Official record key
device-enforcement:Z-1024-2017

Official wording

Reason: 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.

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

Distribution pattern: USA (nationwide) and Internationally to ARGENTINA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.