Food, drugs, devices › MicroPort Orthopedics Inc.

Device recall: Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version

FDA enforcement event 98220 · Class II · initiated 19 Dec 2025 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordArlington, TN

MicroPort Orthopedics Inc. (Arlington, TN) initiated this device recall on 19 Dec 2025; FDA lists 1 product record under event 98220, classified Class II.

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. 85% of the 945 device enforcement events initiated in 2025 carry the same class.

Status: Ongoing. 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

"Due to products not having FDA Premarket authorization to be distributed within the United States."

Distribution

"The product was sent to distributors in multiple US states, including Texas, California, Wisconsin, Kansas, Illinois, Michigan, Tennessee, Maryland, Washington, Georgia, Colorado, Missouri, and…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1133-2026	Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE	91	Class II	Ongoing	28 Jan 2026

Context

85%of 2025 device events are Class II945 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
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
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: "Due to products not having FDA Premarket authorization to be distributed within the United States."

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: "The product was sent to distributors in multiple US states, including Texas, California, Wisconsin, Kansas, Illinois, Michigan, Tennessee, Maryland, Washington, Georgia, Colorado, Missouri, and…"

Is the recall still ongoing?

FDA lists the status as Ongoing. "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.