FDAClass IIJune 8, 2022

Profemur Plasma Z Classic Stem recall

PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK

Why was Profemur Plasma Z Classic Stem recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
Recalling firm
MicroPort Orthopedics Inc.
Quantity
8 units
Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, IN, MO, CA and the country of Canada.
Recall date
June 8, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls