Z-2540-2018Class II

OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 &...

Name: Z-2540-2018 OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 &...
Creator: OMNIlife science Inc.
Published: 2018-05-18
License: https://open.fda.gov/license/

Omni Life Science, Inc. / initiated 2018-05-18 / Terminated / root cause: manufacturing process

FDA source

OMNIlife science Inc. began a recall of OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is intended... on 2018-05-18. FDA classified it as Class II and gives the reason as "The Internal packaging, the pouch and patient labels are improperly labeled". 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-2540-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-18
Posted: 2018-07-25
Terminated: 2019-01-28
Recalling firm: Omni Life Science, Inc.
Product: OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cups are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis Rheumatoid arthritis Correction of functional deformity Congenital dislocation Revision procedures where other treatments or devices have failed
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: The Internal packaging, the pouch and patient labels are improperly labeled.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On May 18, 2108, all US Agents holding the affected inventory were notified via telephone. On May 23, 2018, OMNILife Science, Inc. issued URGENT MEDICAL DEVICE NOTICES to their customers advising them that the product is being recalled, should be quarantined and returned for repackaging. For questions call 774-226-1847 or 800-448-6664.
Quantity in commerce: 16 units
Distribution: US Nationwide Distribution - in the states of AZ, CA, CO, IL, FL & MA
Product codes and lots: Lot Numbers - 29147, 29148 & 29778

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2540-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2540-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-25

Product code LPH

K101976Class IIInterface Acetabular System, Acetabular Insert +4 OffsetOmni Life Science, Inc. / cleared 2010-09-14

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)