ONKOS SURGICAL, INC. — FDA Facility Profile
ONKOS SURGICAL, INC. is an FDA-registered facility (FEI 3013450937) located in Parsippany, NJ, US. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Apr 8, 2022: No Action Indicated (NAI)
- Inspections on record
- 3 (3 NAI)
- Last OAI inspection
- None on record
- Warning letters
- 1 listed by FDA for this FEI, latest Jul 21, 2025
- Recalls as the recalling firm
- 7, latest Jul 24, 2026
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 8, 2022 | No Action Indicated (NAI) | No citations listed |
| Dec 10, 2019 | No Action Indicated (NAI) | No citations listed |
| Jun 7, 2017 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jul 24, 2026 | Class II | Z-0090-2027 | Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left
REF PV-ACREC-04M and 1 more product Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. |
| Jul 11, 2025 | Class II | Z-2423-2025 | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem… and 2 more products Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. |
| May 20, 2025 | Class II | Z-2042-2025 | My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003.
It is a… Required inspections were not performed on finished product prior to release and distribution. |
| Sep 22, 2024 | Class II | Z-1857-2025 | ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E.
Component of ELEOS Limb… Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal… |
| Dec 22, 2023 | Class II | Z-1817-2025 | ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number… and 1 more product Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead… |
| Sep 1, 2023 | Class II | Z-1879-2025 | a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M… and 5 more products Potential for breach of Tyvek seals. |
| May 23, 2017 | Class II | Z-2646-2017 | ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM… and 2 more products The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm |
Facility details
- Company
- Onkos Surgical, Inc.
- Location
- Parsippany, NJ (US)
- Source
- device