Z-2743-2015Class I

PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper...

Name: Z-2743-2015 PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper...
Creator: MicroPort Orthopedics, Inc.
Published: 2015-08-04
License: https://open.fda.gov/license/

Microport Orthopedics Inc. / initiated 2015-08-04 / Terminated / root cause: design

FDA source

MicroPort Orthopedics, Inc. began a recall of PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component on 2015-08-04. FDA classified it as Class I and gives the reason as "Unexpected rate of postoperative fractures resulting in the need for revision surgery". 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-2743-2015
Classification: Class I
Status: Terminated
Initiated: 2015-08-04
Posted: 2015-09-28
Terminated: 2018-08-17
Recalling firm: Microport Orthopedics Inc.
Product: PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.
Product code: MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Reason for recall: Unexpected rate of postoperative fractures resulting in the need for revision surgery.
Root cause tag: design
FDA root cause: Device Design
Action: Micro Port Orthopedics sent a Voluntary Device Product Recall letter dated August 7, 2015, via Fed Ex to all affected customers. The letter identified the product, the problem, and action to be taken by the customer. Customers were instructed to locate and return effected product immediately. Customers with questions were instructed to call 1-866-872-0211. Customers were also asked to return the enclosed form immediately even if they do not have any affected product to return.
Quantity in commerce: 10,489 units
Distribution: Worldwide Distribution - US (nationwide) and Internationally to AT, BE, CA, CN, CZ, DE, ES, FI, FR, GB, IT, KR, LT, LV, NL, NO, PE, PL, PT, RU, and ST.
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2743-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2743-2015	Class I	Terminated	Voluntary: Firm initiated	2015-10-07	2015-09-28

Product code MBL

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)