Recall Z-2743-2015— MicroPort Orthopedics, Inc.

Name: FDA recall Z-2743-2015
Creator: U.S. Food and Drug Administration
Published: 2015-08-04

Class I · Terminated

Class I FDA medical device recall by MicroPort Orthopedics, Inc., initiated 2015-08-04, terminated 2018-08-17. It names 2 FDA 510(k) clearances: K100866, K091423. Product: PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.. Reason: Unexpected rate of postoperative fractures resulting in the need for revision surgery..

Recalling firm: MicroPort Orthopedics, Inc.
Classification: Class I
Status: Terminated
Initiated: 2015-08-04
Terminated: 2018-08-17
Firm location: Arlington, TN, United States

510(k) clearances named in this recall

2 on FDA's record

K100866 — PROFEMUR HIP SYSTEM MODULAR NECKSWrightmedicaltechnologyinc·cleared 2010-04-28
K091423 — PROFEMUR HIP SYSTEM MODULAR NECKSWrightmedicaltechnologyinc·cleared 2009-08-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Unexpected rate of postoperative fractures resulting in the need for revision surgery.

Data sourced from openFDA. This site is unofficial and independent of the FDA.