OMNIlife science Inc.

FDA Regulatory Profile

Summary

Total Recalls
17
510(k) Clearances
7
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0237-2022Class IIOMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as thOctober 1, 2021
Z-0920-2021Class IISERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex ModulDecember 21, 2020
Z-0921-2021Class IISERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex ModulDecember 21, 2020
Z-0922-2021Class IISERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex ModulaDecember 21, 2020
Z-0169-2020Class IIOMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral cSeptember 11, 2019
Z-2481-2019Class IIOMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked AcJuly 23, 2019
Z-2480-2019Class IIOMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup July 23, 2019
Z-2479-2019Class IIOMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup July 23, 2019
Z-1717-2019Class IIOMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is aApril 12, 2019
Z-0837-2019Class IIOMNI K1 Broach Handle, Product Code HS-10054November 29, 2018
Z-2540-2018Class IIOMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-1392May 18, 2018
Z-1117-2018Class IIApex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intNovember 20, 2017
Z-2455-2015Class IIOffset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentatiJune 9, 2015
Z-2454-2015Class IIOffset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentatJune 9, 2015
Z-2445-2015Class IIAPEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. PrJune 4, 2015
Z-2064-2015Class IIApex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip June 3, 2015
Z-2241-2014Class IIApex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HAMay 9, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K201611Apex Knee SystemApril 2, 2021
K172467OMNI ARC Anteverted Neck Hip StemDecember 21, 2017
K171156OMNI Anseris Hip StemAugust 17, 2017
K163332Apex Revision Knee SystemApril 26, 2017
K153437Apex Revision Knee SystemDecember 21, 2015
K133381OMNI ARC MONOBLOCK HIP STEMMarch 13, 2014
K062489APEX HCLA ACETABULAR CUP LINERSAugust 15, 2007