Z-0091-2027

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

Name: Z-0091-2027 Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Creator: Onkos Surgical, Inc.
Published: 2026-07-24
License: https://open.fda.gov/license/

Onkos Surgical, Inc. / initiated 2026-07-24 / Open, Classified

FDA source

Recall record

Recall number: Z-0091-2027
Status: Open, Classified
Initiated: 2026-07-24
Posted: 2026-10-06
Recalling firm: Onkos Surgical, Inc.
Product: Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
FDA root cause: Labeling mix-ups
Action: 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: [email protected]
Quantity in commerce: 1 implant
Distribution: US Nationwide distribution in the states of North Carolina, and California.
Product codes and lots: UDI: B278PVACREC04M0-Lot #C26-0371; Case# C26-0371

Product code LPH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-09. View this recall on fda.gov (opens on fda.gov)