CLASS II Device recall · Reported 24 Aug 2016 · FDA Enforcement Report

Profemur(R) Modular Neck, Hip Femoral Neck MicroPort total recalled

MicroPort Orthopedics is recalling Profemur(R) Modular Neck, Hip Femoral Neck MicroPort total hip systems intended for use. The recall was initiated on 30 Jun 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number 1645222

Quantity recalled14 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-2588-2016
FDA event ID: 74752
Recalling firm: MicroPort Orthopedics, Arlington, TN
Classification: Class II
Status: Terminated
Recall initiated: 30 Jun 2016
FDA classified: 18 Aug 2016
Reported: 24 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

30 Jun 2016	Recall initiated by company
18 Aug 2016	Classified by FDA	+49 days
24 Aug 2016	Published in enforcement report	+6 days

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

Reason for recall

Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck).

Product as listed by the FDA

PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Where it was distributed

Belgium, Italy, Spain, and Poland

Questions about this recall

Why was it recalled?

Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck).

Which lots are affected?

Lot number 1645222

Where was it sold?

Belgium, Italy, Spain, and Poland

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.

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
22 Feb 2023Device	CLASS II	Evolution MP Tibial Bases, Size 7 Left recalled by MicroPort Orthopedics	MicroPort Orthopedics	Packaging Defects	TN

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide