Lower riskMedical device recall · FDA · Published July 24, 2026
Onkos My3D Pelvic Implant Recalled Due to Wrong Customer Distribution
Onkos Surgical recalls My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M due to being mixed up with incorrect customers. This affects 1 implant sold nationwide in North Carolina and California.
“Onkos My3D Pelvic Implant Recalled Due to Wrong Customer Distribution.” GovInfoNow, updated October 21, 2026. https://govinfonow.com/recall/1629779-onkos-surgical-inc-recalls-onkos-surgical-inc-my3d-personalized-pelvic. Based on FDA recall #Z-0091-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0091-2027%22&limit=1).
Onkos Surgical, Inc. voluntarily recalled its My3D Personalized Pelvic Implant on July 24, 2026, after personalized pelvic implants were inadvertently mixed up and distributed to incorrect customers, the Food and Drug Administration said.
How to tell if you have it
Brand: Onkos Surgical
Product: My3D Personalized Pelvic Implant, Porous, Left
REF: PV-ACREC-04M
UDI: B278PVACREC04M0-Lot #C26-0371
Case#: C26-0371
The hazard
Personalized pelvic implants were inadvertently mixed up and distributed to incorrect customers.
Context
GovInfoNow's records show Onkos Surgical, Inc. has had five other recalls since September 2023, including a July 11, 2025 ELEOS Limb Salvage System recall for an unidentified substance hazard and a May 20, 2025 My3D Humeral Cup recall for missing inspections. Other recent recalls of similar products include an EMPOWR 3D Knee Ins 11L 14MM VE Product Mix-Up on February 16, 2026, and a Medtronic Octopus Nuvo Tissue Stabilizer Recall for incorrect tube assembly on January 13, 2026.
How to tell if you have this one
Check for the implant reference number PV-ACREC-04M and lot number C26-0371 on the packaging. The product was distributed in North Carolina and California.
Brand
Onkos Surgical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of North Carolina, and California.
Recall number
Product, codes & lots
Z-0090-2027
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M; UDI: B278PVACREC04M0-Lot# C26-0346; Case# C26-0346,
Z-0091-2027
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M; UDI: B278PVACREC04M0-Lot #C26-0371; Case# C26-0371
Based on the official FDA remedy
What to do — step by step
Check Your Implant Details
Look for the reference number PV-ACREC-04M and lot number C26-0371 on the implant packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of North Carolina, and California.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, North Carolina.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0091-2027 (July 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0091-2027 to see it in context.
Plain-language summary written by qwen3:4b on October 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.