Z-0169-2020Class II

OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a...

Name: Z-0169-2020 OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a...
Creator: OMNIlife science Inc.
Published: 2019-09-11
License: https://open.fda.gov/license/

Omni Life Science, Inc. / initiated 2019-09-11 / Terminated

FDA source

OMNIlife science Inc. began a recall of OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement on 2019-09-11. FDA classified it as Class II and gives the reason as "Stems missing porous coating on the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0169-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-11
Posted: 2019-10-21
Terminated: 2020-04-27
Recalling firm: Omni Life Science, Inc.
Product: OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Stems missing porous coating on the device.
FDA root cause: Under Investigation by firm
Action: 1. Identify the affected product in your inventory 2.Immediately hold or quarantine the Lot # 33035 3. Return Product to OMNI at 480 Paramount Drive, Raynham MA 02767 3. Fill out the acknowledgement form and return the Form by FAX to 508-819-3390 or my email to [email protected] For further information contact Christina Rovaldi, Regulatory Affairs Manager at 774- 226-1847 or 800-448-6664. Company contact hours are Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.
Quantity in commerce: 3 units
Distribution: OK, IL
Product codes and lots: Lot # 33035

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0169-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0169-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-21

Product code LPH

K060072Class IIMonoblock Press-Fit Hip StemOmni Life Science, Inc. / cleared 2006-08-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)