CLASS II Device recall · Reported 22 Feb 2023 · FDA Enforcement Report

Evolution MP Tibial Bases, Size 7 Left recalled by MicroPort Orthopedics

MicroPort Orthopedics is recalling Evolution MP Tibial Bases, Size 7 Left. The recall was initiated on 28 Oct 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 0 0192629 08293 9, Lot 1916715

Quantity recalled22 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0276-2023
FDA event ID: 91102
Recalling firm: MicroPort Orthopedics, Arlington, TN
Classification: Class II
Status: Terminated
Recall initiated: 28 Oct 2022
FDA classified: 22 Nov 2022
Reported: 22 Feb 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

28 Oct 2022	Recall initiated by company
22 Nov 2022	Classified by FDA	+25 days
22 Feb 2023	Published in enforcement report	+92 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base

Where it was distributed

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

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI/DI 0 0192629 08293 9, Lot 1916715

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 91102

Reported	Class	Recall	Company	Reason	Where
22 Feb 2023	CLASS II	Evolution MP Tibial Bases, Size 2+ Left recalled	MicroPort Orthopedics	Packaging Defects	TN

More recalls from MicroPort Orthopedics

All 31

Reported	Class	Recall	Company	Reason	Where
28 Jan 2026Device	CLASS II	MicroPort Hipturn Fem Head Trial Reusable recalled	MicroPort Orthopedics	Device Malfunction	13 states
25 Dec 2024Device	CLASS II	Evolution Mp Femoral Component Cs/cr Porous Size 5 Right Primary recalled	MicroPort Orthopedics	Packaging Defects	TN
10 Jul 2024Device	CLASS II	Evolution¿ MP Femoral CS/CR Non-Porous MicroPort total recalled	MicroPort Orthopedics	Packaging Defects	TN
22 Feb 2023Device	CLASS II	Evolution MP Tibial Bases, Size 2+ Left recalled	MicroPort Orthopedics	Packaging Defects	TN
8 Jun 2022Device	CLASS II	Profemur Plasma Z Classic Stem Size 7 Standard Short Neck recalled	MicroPort Orthopedics	Other	Nationwide

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All 3,111

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