Recall Z-2540-2018— OMNIlife science Inc.

Name: FDA recall Z-2540-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-18

Class II · Terminated

Class II FDA medical device recall by OMNIlife science Inc., initiated 2018-05-18, terminated 2019-01-28. It names one FDA 510(k) clearance: K101976. 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. Reason: The Internal packaging, the pouch and patient labels are improperly labeled..

Recalling firm: OMNIlife science Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-18
Terminated: 2019-01-28
Firm location: Raynham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K101976 — INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSETOmni Life Science, Inc.·cleared 2010-09-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

The Internal packaging, the pouch and patient labels are improperly labeled.

Data sourced from openFDA. This site is unofficial and independent of the FDA.