Skip to content
Recall Observatory FDA recall evidence

Device product

Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152

Z-1025-2017

December 19, 2016

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 75970
Status
Terminated
Classification
Class II
Quantity
19
Official record key
device-enforcement:Z-1025-2017

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-200152 Lot 339260 UDI (01)00880304491366(17)210713(10)339260

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.