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Open, Classified

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

FDA Recall Z-0091-2027 · Posted 2026-10-06

Recalling FirmOnkos Surgical, Inc.
Recall StatusOpen, Classified
Product CodeLPH
Date Initiated2026-07-24
Product Quantity1 implant

Reason for Recall

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

Firm 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]

Root Cause

Labeling mix-ups

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K223348My3D® Personalized Pelvic ReconstructionOnkos Surgical, Inc. · 2023-01-30K212815My3D® Personalized Pelvic ReconstructionOnkos Surgical · 2022-07-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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