Z-2454-2015Class II

Offset Femoral Alignment Guide, 2mm x 6

Name: Z-2454-2015 Offset Femoral Alignment Guide, 2mm x 6
Creator: Omnilife Science Inc.
Published: 2015-06-09
License: https://open.fda.gov/license/

Omni Life Science, Inc. / initiated 2015-06-09 / Terminated / root cause: design

FDA source

Omnilife Science Inc. began a recall of Offset Femoral Alignment Guide, 2mm x 6; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and... on 2015-06-09. FDA classified it as Class II and gives the reason as "The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2454-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-09
Posted: 2015-08-24
Terminated: 2015-09-28
Recalling firm: Omni Life Science, Inc.
Product: Offset Femoral Alignment Guide, 2mm x 6; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
Product code: FZX Guide, Surgical, Instrument
Reason for recall: The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
Root cause tag: design
FDA root cause: Device Design
Action: Omni sent an Urgent Medical Device -Field Safety Notice letters to their customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to Return the attached Acknowledgement and Receipt Form by FAX to 508-819-3390.
Quantity in commerce: 15
Distribution: Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia.
Product codes and lots: Lot Numbers: MM0314R, VA0713, Z1111

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2454-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2454-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-24
Z-2455-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-24

Product code FZX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)