Z-2941-2020Class I

PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254...

Name: Z-2941-2020 PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254...
Creator: MicroPort Orthopedics Inc.
Published: 2020-07-31
License: https://open.fda.gov/license/

Microport Orthopedics Inc. / initiated 2020-07-31 / Terminated / root cause: design

FDA source

MicroPort Orthopedics Inc. began a recall of PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component on 2020-07-31. FDA classified it as Class I and gives the reason as "MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-Long PROFEMUR...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2941-2020
Classification: Class I
Status: Terminated
Initiated: 2020-07-31
Posted: 2020-09-18
Terminated: 2024-04-16
Recalling firm: Microport Orthopedics Inc.
Product: PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
Product code: LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Reason for recall: MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-Long PROFEMUR Titanium modular neck fractures among 123,840 global sales representing is a cumulative rate of modular neck device fracture of 0.55% from 2002 to 2019. Within the United States there were 349 Long and X-Long PROFEMUR Titanium modular neck fractures among 15,786 United States sales representing a cumulative rate of modular neck device fracture with a fracture rate in the United States of 2.21% from 2002 to 2019. There is an average time of 5.4 years to device fracture after implantation.
Root cause tag: design
FDA root cause: Device Design
Action: The firm initiated the recall by letter on 07/31/2020. The letter provide the following instructions: "Distributors: 1. Please immediately cease use and distribution of these products. 2. Please check your stock, including all consignment stock to immediately determine if you have any affected product. 3. Please complete the form on the last page of this notification and return the form and any affected products to MicroPort Orthopedics per the Actions section of this notification. 4. Please assist us by distributing this notification to all hospitals and surgeons in your territory and collecting and returning completed forms to MicroPort Orthopedics. NOTE: This notice will also be sent directly to the hospitals and surgeons, however they only need to complete the information once, either provided through the distributor or send directly back to MicroPort Orthopedics. Hospitals: 1. Please immediately cease use of these products. 2. Please complete the form on the last page of this notification and return the form and any affected products to MicroPort Orthopedics per the Actions section of this notification. Surgeons: 1. Please immediately cease use of these products. 2. You can continue to monitor your patients per your normal protocol. There are no diagnostic techniques which can predict an unexpected postoperative failure. 3. Should a patient present with sudden pain, instability and difficulty walking/performing common tasks a postoperative fracture can be confirmed via x-ray. 4. Please sign and return this form per the instructions to confirm your notification of this action. ACTIONS: 1. Please complete and return the enclosed form immediately even if you do not have any affected product to return. This information is essential in order to carry out effectiveness checks required per FDA guidelines. Return the completed form by fax to: 901-867-4771, or by e-mail to: [email protected]. Please feel free to
Quantity in commerce: 123,284 units
Distribution: worldwide, except China and Japan
Product codes and lots: All lots/serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2941-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2941-2020	Class I	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-18
Z-2942-2020	Class I	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-18

Product code LWJ

K003016Class IIPro-Femur RWrightmedicaltechnologyinc / cleared 2000-12-13

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)