Food, drugs, devices › MicroPort Orthopedics, Inc.

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

FDA enforcement event 71925 · Class I · initiated 4 Aug 2015 · status Terminated · terminated 17 Aug 2018

DeviceVoluntary: Firm initiated1 product recordArlington, TN

FDA enforcement event 71925 is a device recall by MicroPort Orthopedics, Inc. of Arlington, TN, initiated 4 Aug 2015 and classified Class I, with 1 product record.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 4% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 17 Aug 2018. Initiation: voluntary: firm initiated. MicroPort Orthopedics, Inc. has 15 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

MicroPort Orthopedics, Inc., Arlington, TN.

Reason for recall

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

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 records

Recall number	Product	Quantity	Class	Status	Report date
Z-2743-2015	PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.	10,489 units	Class I	Terminated	7 Oct 2015

Context

4%of 2015 device events are Class I1,153 events that year

1product record in this eventfirm median: 1

15events on this register for the firm

Other enforcement events for MicroPort Orthopedics, Inc.

Initiated	Product (first record)	Type	Class	Records
19 Dec 2025	Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version	Device	Class II	1
29 Oct 2024	EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NO	Device	Class II	1
3 May 2024	EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.	Device	Class II	1
28 Oct 2022	EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base	Device	Class II	2
4 May 2022	PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK	Device	Class II	1
31 Jul 2020	PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip	Device	Class I	2
31 Jul 2020	PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2	Device	Class II	1
18 Sep 2017	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems ar	Device	Class II	1
17 Nov 2016	PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support t	Device	Class II	1
30 Jun 2016	PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for re	Device	Class II	1

All 15 events for MicroPort Orthopedics, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Unexpected rate of postoperative fractures resulting in the need for revision surgery."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "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."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 17 Aug 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.