Device recall: EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base

Class II FDA enforcement event 91102. Recall start date: 28 Oct 2022. Status in the FDA record: Terminated. Termination date: 10 Sep 2026.

Reason for recall, in the words of FDA

One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.

Class II, in the words of FDA

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

MicroPort Orthopedics Inc. started this device recall on 28 Oct 2022. The firm address in the FDA record is in Arlington, TN. FDA put the recall in Class II. FDA event 91102 has 2 product records. The first FDA enforcement report date is 22 Feb 2023. The record gives the status Terminated, with the termination date 10 Sep 2026.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.

Recalling firm

MicroPort Orthopedics Inc., Arlington, TN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 91102: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0275-2023	EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base	24 units	Class II	Terminated	22 Feb 2023
Z-0276-2023	EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base	22 units	Class II	Terminated	22 Feb 2023

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2022: 839
Share of these events in Class II: 88%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 15

Other events of the firm

Other FDA enforcement events of 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
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

MicroPort Orthopedics Inc.: all 15 events

Official channels

FDA enforcement report Z-0275-2023The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 91102. https://recallregister.com/fda/ii/91102/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.
What quantity of product is in FDA event 91102?: The event has 2 product records. The first record gives this quantity: 24 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2022 have the same class?: 88% of the 839 device events that started in 2022 are in Class II.