Class II recallOngoing

Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M recall — FDA event 99692

FDA · FDA event 99692 · FDA posted Oct 6, 2026

Published by MedWatcher Oct 28, 2026Record source last checked: 2026-10-28 03:25:03 UTC

What happened

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

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

On July 24, 2026, Onkos Surgical Inc. issued a medical device recall to affected consignees via email. Onkos Surgical Inc. informed consignees of the following actions to be taken:
1.Segregate and quarantine the product immediately. 2.Within two business days, complete the Product and Distribution Table within the medical device recall document and acknowledge receipt of this letter. 3. Return your existing implants for inspection within 2 business days after signing the acknowledgement. Return to: Onkos Surgical, Inc., Attention: Matt Avioli, 77 East Halsey Road, Parsippany, NJ 07054 4. Contact Matt Avioli for questions:Phone: 781-223-0938, Email contact: mavioli@onkossurgical.com

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M by Onkos Surgical, Inc..

Products affected by FDA event 99692
Model	Description	Lot / serial range	Manufactured	Status
Z-0090-2027	Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M	UDI: B278PVACREC04M0-Lot# C26-0346; Case# C26-0346,	Not provided in the normalized record	Ongoing
Z-0091-2027	Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M	UDI: B278PVACREC04M0-Lot #C26-0371; Case# C26-0371	Not provided in the normalized record	Ongoing

Distribution: US Nationwide distribution in the states of North Carolina, and California.
Units affected: See official FDA record
Category: Hip implants

Timeline

Jul 24, 2026
Recall initiated
Date recorded by the FDA.
Oct 6, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 28, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 99692
Published: Oct 6, 2026
Source checked: 2026-10-28 03:25:03 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, recall — FDA event 97765

Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.

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Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M recall — FDA event 99692

FDA · FDA event 99692 · FDA posted Oct 6, 2026

Published by MedWatcher Oct 28, 2026Record source last checked: 2026-10-28 03:25:03 UTC

Affected products and models

This FDA record lists Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M by Onkos Surgical, Inc..

Products affected by FDA event 99692
Model	Description	Lot / serial range	Manufactured	Status
Z-0090-2027	Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M	UDI: B278PVACREC04M0-Lot# C26-0346; Case# C26-0346,	Not provided in the normalized record	Ongoing
Z-0091-2027	Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M	UDI: B278PVACREC04M0-Lot #C26-0371; Case# C26-0371	Not provided in the normalized record	Ongoing

Distribution

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

Units affected

See official FDA record

Klassic BiPolar Head recall — FDA event 97708

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

FDA · FDA event 97708Posted Nov 5, 2025

Class II recallOngoing

Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, recall — FDA event 97765

FDA · FDA event 97765Posted Nov 3, 2025

Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M recall — FDA event 99692

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What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M recall — FDA event 99692

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

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline