Recall Z-0091-2027 · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Onkos Surgical, Inc.
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
| Date | Oct 6, 2026 (initiated Jul 24, 2026) |
| Status | Open, Classified |
| Reason | Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. |
| Root cause | Labeling mix-ups |
| 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. Co |
| Quantity | 1 implant |
| Distribution | US Nationwide distribution in the states of North Carolina, and California. |
| FDA record | Open on fda.gov |