CLASS II ONGOING Device recall · Reported 31 Aug 2022 · FDA Enforcement Report

Hana/PROFx Classic Femoral Hook Right recalled by Mizuho OSI

Mizuho OSI is recalling Hana/PROFx Classic Femoral Hook Right, distributed nationwide in the US. The recall was initiated on 29 Jul 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 6850-144 UDI Code: (01)00842430106842(10)MIZ210712(11)210712 Lot/Batch Number: MIZ210712

Quantity recalled13 devices

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-1573-2022
FDA event ID: 90603
Recalling firm: Mizuho OSI, Union City, CA
Classification: Class II
Status: Ongoing
Recall initiated: 29 Jul 2021
FDA classified: 24 Aug 2022
Reported: 31 Aug 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

29 Jul 2021	Recall initiated by company
24 Aug 2022	Classified by FDA	+391 days
31 Aug 2022	Published in enforcement report	+7 days

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

Reason for recall

One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.

Product as listed by the FDA

HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

Where it was distributed

U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada

Nationwide California Florida Georgia Michigan Nebraska New Jersey Tennessee Utah Washington

Questions about this recall

Why was it recalled?

One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.

Which lots are affected?

Model Number: 6850-144 UDI Code: (01)00842430106842(10)MIZ210712(11)210712 Lot/Batch Number: MIZ210712

Where was it sold?

U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada

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 Mizuho OSI

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21 Oct 2020Device	CLASS II	Levo Arm Label: LEVO ARM recalled by Mizuho OSI	Mizuho OSI	Device Malfunction	Nationwide
26 Apr 2017Device	CLASS II	216 Wilson Frame Pads recalled by Mizuho OSI	Mizuho OSI	Foreign Material	CA
17 Feb 2016Device	CLASS II	Trios, Table Base recalled by Mizuho OSI	Mizuho OSI	Other	CA
20 Feb 2013Device	CLASS II	Mizuho Orthopedic Table recalled by Mizuho OSI	Mizuho OSI	Potency & Assay	48 states

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