Class II recall Z-0090-2027: Onkos Surgical, Inc.
Class II recall Z-0090-2027: Onkos Surgical, Inc. (New Jersey): Onkos Surgical, Inc. Dated 22 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 17 related NJ FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0090-2027 |
| Recalling firm | Onkos Surgical, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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. |
| Quantity | 1 implant |
| Distribution | US Nationwide distribution in the states of North Carolina, and California. |
| Recall initiated | 2026-07-24 |
| Reported | 2026-10-14 |
| Firm location | Parsippany, NJ, United States |
| Peer records CSV (18 NJ records) | 🔒 Click to unlock → |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-14
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Class II recall Z-0090-2027: Onkos Surgical, Inc. and 18 New Jersey peers
- New Jersey FDAPulse records like this one: 18
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every New Jersey peer: $3,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
62 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 22 days ago.
What is the FDAPulse record for Class II recall Z-0090-2027: Onkos Surgical, Inc. in New Jersey?
Class II device recall Z-0090-2027 by Onkos Surgical, Inc.: Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
How does Class II recall Z-0090-2027: Onkos Surgical, Inc. compare to other New Jersey FDAPulse records?
It is 22 days old, still within a typical 45-day follow-up window.
Class II recall Z-0090-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0090-2027 | NJ | 2026-10-14 |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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