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Recall Observatory FDA recall evidence

Device product

Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104

Z-0635-2022

December 14, 2021

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 89443
Status
Ongoing
Classification
Class II
Quantity
271 units
Official record key
device-enforcement:Z-0635-2022

Official wording

Reason: Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process

Code information: Lot Numbers: 50971615, 50971617 & 50967788

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of CO, CT, FL, MA, MD, OR, PA, WI and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process