Z-2588-2016Class II

PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip...

Name: Z-2588-2016 PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip...
Creator: MicroPort Orthopedics Inc.
Published: 2016-06-30
License: https://open.fda.gov/license/

Microport Orthopedics Inc. / initiated 2016-06-30 / Terminated / root cause: labeling and UDI

FDA source

MicroPort Orthopedics Inc. began a recall of PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain and/or... on 2016-06-30. FDA classified it as Class II and gives the reason as "Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2588-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-30
Posted: 2016-08-18
Terminated: 2017-01-21
Recalling firm: Microport Orthopedics Inc.
Product: PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Product code: LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Reason for recall: Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck).
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm initiated their recall by email on 06/30/2016.
Quantity in commerce: 14 units
Distribution: Belgium, Italy, Spain, and Poland
Product codes and lots: Lot number 1645222

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2588-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2588-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-18

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)