Onkos Surgical Inc. My3D Personalized Pelvic Implant… recallZ-0091-2027 · Onkos Surgical, Inc. · initiated Jul 24, 2026
Open, Classified All recalls posted in October 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Onkos Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
FDA root cause category: Labeling mix-ups
What the company is doing
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]
Recall details
- Recall number
- Z-0091-2027
- Recall class
- Not yet classified by the FDA
- Status
- Open, Classified
- Initiated by the company
- Jul 24, 2026
- Posted by the FDA
- Oct 6, 2026
- Recalling firm
- Onkos Surgical, Inc.
- Quantity
- 1 implant
- Product code
- LPH
- FDA submissions
- K212815, K223348
- Distribution
- US Nationwide distribution in the states of North Carolina, and California.
Product description
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Code information (models, lots, serial numbers)
UDI: B278PVACREC04M0-Lot #C26-0371; Case# C26-0371
Other devices under the same FDA submission
15 devices cleared under K212815, K223348 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- My3D® Personalized Pelvic Reconstruction PV-ACREC-04MOnkos Surgical, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented11 reports
- My3D® Personalized Pelvic Reconstruction CS-65025-04MOnkos Surgical, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented6 reports
- My3D® Personalized Pelvic Reconstruction DR-43200-04NOnkos Surgical, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented5 reports
- My3D® Personalized Pelvic Reconstruction CS-65015-04MOnkos Surgical, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented3 reports
- My3D® Personalized Pelvic Reconstruction AM-M3DMD-04NOnkos Surgical, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- My3D® Personalized Pelvic Reconstruction CS-65020-04MOnkos Surgical, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- My3D® Personalized Pelvic Reconstruction CS-65075-04MOnkos Surgical, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- My3D® Personalized Pelvic Reconstruction CS-65090-04MOnkos Surgical, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- My3D® Personalized Pelvic Reconstruction CS-65095-04MOnkos Surgical, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- My3D® Personalized Pelvic Reconstruction AP-38016-04MOnkos Surgical, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- My3D® Personalized Pelvic Reconstruction CS-65050-04MOnkos Surgical, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- My3D® Personalized Pelvic Reconstruction CS-65055-04MOnkos Surgical, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 99692).
- Z-0090-2027 · Open, ClassifiedOnkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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