Onkos Surgical, Inc.: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
- Recalling firm
- Onkos Surgical, Inc.
- Product
- Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
- Reason
- Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-24
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of North Carolina, and California.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/110c85a0-5581-4bad-966d-f56dcc47b301