medical MODERATE Updated 2026-10-14

Onkos Surgical, Inc. recalls Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous

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Recalled Product

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

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: B278PVACREC04M0-Lot# C26-0346; Case# C26-0346,

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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