Facility

ONKOS SURGICAL, INC.

6 recall(s) on record — most severe on record: Class II.

Key facts

6recalls · worst Class II

3inspections · worst NAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3013450937
Establishment type	Manufacture Medical Device
Location	77 E HALSEY RD Parsippany, NJ, US 07054
Registration status	Active · expires 2026
Parent company	Onkos Surgical (owner-operator 10054049)
Brand names	My3D Personalized Pelvic Reconstruction

Activity by year

Recalls (6)
Inspections (3)
Warning letters (1)

Devices registered here (1)

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Product code LPH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3358

Recalls & enforcement

Class IIOngoing2025-07-11
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Class IIOngoing2025-05-20
Required inspections were not performed on finished product prior to release and distribution.
Class IIOngoing2024-09-22
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
Class IIOngoing2023-12-22
Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
Class IIOngoing2023-09-01
Potential for breach of Tyvek seals.
Class IITerminated2017-05-23
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm

FDA inspections (3)

NAI2022-04-08
No Action Indicated · Compliance: Devices
NAI2019-12-10
No Action Indicated · Compliance: Devices
NAI2017-06-07
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2025-07-21
Warning Letter (opens in a new tab) · Parsippany New Jersey

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by Onkos Surgical

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ONKOS SURGICAL, INC. (FEI 3013450937) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013450937-onkos-surgical-inc/

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