FDAFDA recall Z-0091-2027 · Oct 14, 2026
Onkos Surgical, Inc.: Onkos Surgical Inc recall
Recall found
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI: B278PVACREC04M0-Lot #C26-0371; Case# C26-0371
- Quantity
- 1 implant
- Distribution
- US Nationwide distribution in the states of North Carolina, and California.
- Recalling firm
- Onkos Surgical, Inc., Parsippany, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-24
Source: openFDA enforcement record Z-0091-2027 · search recall number Z-0091-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.