Recall Z-0091-2027
- Recall number
- Z-0091-2027
- Event number
- 99692
- Firm
- Onkos Surgical, Inc.
- Firm FEI
- 3013450937
- Product code
- LPH
- Status
- Open, Classified
- Initiated
- 2026-07-24
- Posted
- 2026-10-06
- Root cause
- Labeling mix-ups
- 510(k) numbers
- K212815, K223348, K010120, K852198, K202472, K233498, K102975, K061434, K951000, K200607, K201733, K951095, K032729, K211866, K973675, K122099, K062489, K060031, K993259, K243456, K935484, K141797, K121684, K052089, K011489, K000538, K013475, K953337, K123019, K053293
Product#
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Reason for Recall#
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.