- Recalling firm
- Onkos Surgical, Inc.
- Reason for recall
- Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
- Affected products (lot / model / serial)
- UDI: B278PVACREC04M0-Lot# C26-0346; Case# C26-0346,
- Units affected
- 1 implant
- Distribution pattern
- US Nationwide distribution in the states of North Carolina, and California.
- Firm location
- Parsippany, NJ, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0090-2027
- Recall initiated
- July 24, 2026
- FDA classification date
- October 6, 2026
- FDA report date
- October 14, 2026
- FDA event ID
- 99692
- Last updated on HTM Vibe
- October 21, 2026
