CLASS II ONGOING Device recall · Reported 23 Aug 2023 · FDA Enforcement Report

Hip-screw-, Sterile Eo recalled by Conformis

Conformis is recalling Hip-screw-, Sterile Eo, distributed nationwide in the US. The recall was initiated on 16 Jun 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. HAA-030-0625-000101; UDI-DI: M572HAA0300625011; Lot No. 1232071.

Quantity recalled25 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-2405-2023
FDA event ID: 92764
Recalling firm: Conformis, Billerica, MA
Classification: Class II
Status: Ongoing
Recall initiated: 16 Jun 2023
FDA classified: 16 Aug 2023
Reported: 23 Aug 2023
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

16 Jun 2023	Recall initiated by company
16 Aug 2023	Classified by FDA	+61 days
23 Aug 2023	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

30mm screws were labeled as 25mm screws.

Product as listed by the FDA

CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO

Where it was distributed

US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA.

Nationwide California Florida Georgia Kansas Massachusetts Nevada New York Tennessee Virginia

Questions about this recall

Why was it recalled?

30mm screws were labeled as 25mm screws.

Which lots are affected?

Model No. HAA-030-0625-000101; UDI-DI: M572HAA0300625011; Lot No. 1232071.

Where was it sold?

US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA.

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 Conformis

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23 Apr 2025Device	CLASS II	restor3d Cordera Hip System recalled by Conformis	Conformis	Labeling Errors	Nationwide
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2 Dec 2020Device	CLASS II	iTotal Hip Replacement System recalled by Conformis	Conformis	Other	CA

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