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Recall Observatory FDA recall evidence

Device product

Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.

Z-2499-2019

July 24, 2019

Class II

Product summary

Firm
Exactech, Inc.
Event
Event 83520
Status
Terminated
Classification
Class II
Quantity
22 devices
Official record key
device-enforcement:Z-2499-2019

Official wording

Reason: The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.

Code information: Catalog Number 181-02-01, Lot Numbers 103071001, UDI Number 10885862520623. Expansion on 09/09/2019 to include Lot Number 8182001

Distribution pattern: US distribution to AR, CA, FL, IL, IN, NY, SC, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.