Z-1225-2022Class II

Profemur Plasma Z Classic Stem Size 7 Standard Short Neck

Name: Z-1225-2022 Profemur Plasma Z Classic Stem Size 7 Standard Short Neck
Creator: MicroPort Orthopedics Inc.
Published: 2022-05-04
License: https://open.fda.gov/license/

Microport Orthopedics Inc. / initiated 2022-05-04 / Terminated / root cause: manufacturing process

FDA source

MicroPort Orthopedics Inc. began a recall of PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK on 2022-05-04. FDA classified it as Class II and gives the reason as "One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1225-2022
Classification: Class II
Status: Terminated
Initiated: 2022-05-04
Posted: 2022-06-02
Terminated: 2024-01-16
Recalling firm: Microport Orthopedics Inc.
Product: Profemur Plasma Z Classic Stem Size 7 Standard Short Neck
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: The firm sent out a recall notification to the distributors on 05/04/2022 via email. Phone calls were also made to the distributors. Additionally, the US field communication letter was mailed to the surgeon and facility in regard to the one case of implantation on May 10, 2022. The consignee letter informed the consignee to cease use and distribution of the affected product, check inventory for affected product, complete the response form, return affected product and notify affected consignees. The field surgeon letter and hospital letter informs the consignee to cease use and distribution of the affected product, monitor patients per normal protocol, return affected product and sign and return the response form.
Quantity in commerce: 8 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, IN, MO, CA and the country of Canada.
Product codes and lots: Catalog Number(s): PHAPCLS7; Lot Number(s): 1903727; Expiration Date: 11/24/2029; UDI/DI Number: 00192629112773

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1225-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1225-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-08	2022-06-02

Product code JDI

K123434Class IIProfemur Z Classic StemsWrightmedicaltechnologyinc / cleared 2013-02-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)