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Recall Observatory FDA recall evidence

Device product

PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK

Z-1225-2022

May 04, 2022

Class II

Product summary

Firm
MicroPort Orthopedics Inc.
Event
Event 90140
Status
Terminated
Classification
Class II
Quantity
8 units
Official record key
device-enforcement:Z-1225-2022

Official wording

Reason: One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.

Code information: Catalog Number(s): PHAPCLS7; Lot Number(s): 1903727; Expiration Date: 11/24/2029; UDI/DI Number: 00192629112773

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of FL, IN, MO, CA and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.