Z-0237-2022Class II

OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral...

Name: Z-0237-2022 OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral...
Creator: OmniLife Science
Published: 2021-10-01
License: https://open.fda.gov/license/

Omni Life Science, Inc. / initiated 2021-10-01 / Terminated / root cause: manufacturing process

FDA source

OmniLife Science began a recall of OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This... on 2021-10-01. FDA classified it as Class II and gives the reason as "The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0237-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-01
Posted: 2021-11-16
Terminated: 2022-07-20
Recalling firm: Omni Life Science, Inc.
Product: OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Affected agents and representatives were notified by email, with initial communication sent via a quarantine form on 10/1/21. Additional notices titled "Urgent Medical Device Recall" were emailed out on October 15, 2021. Customers were instructed to immediately quarantine lot 38933 and return the product to OMNI. Customers were provided with a response form and asked to complete and return the form to the recalling company by FAX to 508-819-3390 or my email at [email protected]. For further information contact Christina Rovaldi, RA/QA 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: 7
Distribution: US Distribution to states of: Colorado and Virginia.
Product codes and lots: UDI 00841690102496 Lot 38933

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0237-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0237-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-24	2021-11-16

Product code LPH

K041950Class IIApex K2 Hip SystemApex Surgical, LLC / cleared 2004-12-21

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)