OMNIlife science Inc.
FDA Regulatory Profile
OMNIlife science Inc. appears in FDA public data with 17 recalls, 7 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0237-2022, Class II) was initiated on October 1, 2021. Its most recent 510(k) clearance was granted on April 2, 2021.
Summary
- Total Recalls
- 17
- 510(k) Clearances
- 7
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0237-2022 | Class II | OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as th | October 1, 2021 |
| Z-0922-2021 | Class II | SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modula | December 21, 2020 |
| Z-0921-2021 | Class II | SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modul | December 21, 2020 |
| Z-0920-2021 | Class II | SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modul | December 21, 2020 |
| Z-0169-2020 | Class II | OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral c | September 11, 2019 |
| Z-2481-2019 | Class II | OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Ac | July 23, 2019 |
| Z-2480-2019 | Class II | OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup | July 23, 2019 |
| Z-2479-2019 | Class II | OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup | July 23, 2019 |
| Z-1717-2019 | Class II | OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a | April 12, 2019 |
| Z-0837-2019 | Class II | OMNI K1 Broach Handle, Product Code HS-10054 | November 29, 2018 |
| Z-2540-2018 | Class II | OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-1392 | May 18, 2018 |
| Z-1117-2018 | Class II | Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is int | November 20, 2017 |
| Z-2454-2015 | Class II | Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentat | June 9, 2015 |
| Z-2455-2015 | Class II | Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentati | June 9, 2015 |
| Z-2445-2015 | Class II | APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Pr | June 4, 2015 |
| Z-2064-2015 | Class II | Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip | June 3, 2015 |
| Z-2241-2014 | Class II | Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA | May 9, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K201611 | Apex Knee System | April 2, 2021 |
| K172467 | OMNI ARC Anteverted Neck Hip Stem | December 21, 2017 |
| K171156 | OMNI Anseris Hip Stem | August 17, 2017 |
| K163332 | Apex Revision Knee System | April 26, 2017 |
| K153437 | Apex Revision Knee System | December 21, 2015 |
| K133381 | OMNI ARC MONOBLOCK HIP STEM | March 13, 2014 |
| K062489 | APEX HCLA ACETABULAR CUP LINERS | August 15, 2007 |