CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report

My3D Personalized Pelvic Implant, Porous, Left recalled

Onkos Surgical is recalling My3D Personalized Pelvic Implant, Porous, Left, distributed nationwide in the US. The recall was initiated on 24 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: B278PVACREC04M0-Lot #C26-0371; Case# C26-0371

Quantity recalled1 implant

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-0091-2027
FDA event ID: 99692
Recalling firm: Onkos Surgical, Parsippany, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 24 Jul 2026
FDA classified: 6 Oct 2026
Reported: 14 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

24 Jul 2026	Recall initiated by company
6 Oct 2026	Classified by FDA	+74 days
14 Oct 2026	Published in enforcement report	+8 days

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

Reason for recall

Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

Product as listed by the FDA

Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M

Where it was distributed

US Nationwide distribution in the states of North Carolina, and California.

Nationwide California North Carolina

Questions about this recall

Why was it recalled?

Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

Which lots are affected?

UDI: B278PVACREC04M0-Lot #C26-0371; Case# C26-0371

Where was it sold?

US Nationwide distribution in the states of North Carolina, and California.

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 21 Oct 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 99692

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026	CLASS II	My3D Personalized Pelvic Implant, Porous, Left recalled	Onkos Surgical	Other	Nationwide

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