Food, drugs, devices › MicroPort Orthopedics Inc.

Device recall: PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK

FDA enforcement event 90140 · Class II · initiated 4 May 2022 · status Terminated · terminated 16 Jan 2024

DeviceVoluntary: Firm initiated1 product recordArlington, TN

FDA enforcement event 90140 is a device recall by MicroPort Orthopedics Inc. of Arlington, TN, initiated 4 May 2022 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.

Status: Terminated, terminated 16 Jan 2024. 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

"One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body."

Distribution

"Worldwide distribution - US Nationwide distribution in the states of FL, IN, MO, CA and the country of Canada."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1225-2022	PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK	8 units	Class II	Terminated	8 Jun 2022

Context

88%of 2022 device events are Class II839 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
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
21 Jun 2016	Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70	Device	Class III	7

All 15 events for MicroPort Orthopedics Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide distribution in the states of FL, IN, MO, CA and the country of Canada."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 16 Jan 2024. "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.