Recall Register

Food, drugs, devices › Firms

OMNIlife science Inc.

FDA recalling firm · 11 enforcement events · 16 product records · 2014–2020 · MA

OMNIlife science Inc. has 11 FDA enforcement events on this register (16 product records) between 2014 and 2020: 11 device; the busiest year was 2015 with 3.

0% of its events are Class I; the most common class is Class II (11). 0 events are listed as ongoing; the recalling firm's address is in MA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
21 Dec 2020SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-25128DeviceClass II3Terminated
11 Sep 2019OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.DeviceClass II1Terminated
23 Jul 2019OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328DeviceClass II3Terminated
12 Apr 2019OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock Cutting Guide is used in conjunction with the iBlock Saw Guide with the OMNIBot robotic Motor Unit, and for preparation…DeviceClass II1Terminated
29 Nov 2018OMNI K1 Broach Handle, Product Code HS-10054DeviceClass II1Terminated
18 May 2018OMNI 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…DeviceClass II1Terminated
20 Nov 2017Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as…DeviceClass II1Terminated
9 Jun 2015Offset 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 SystemsDeviceClass II2Terminated
4 Jun 2015APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.DeviceClass II1Terminated
3 Jun 2015Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy.…DeviceClass II1Terminated
9 May 2014Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HADeviceClass II1Terminated

By type and class

Device11
Class II11

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

14
16
18
20
22
24
26
Enforcement events for OMNIlife science Inc. by year initiated.

Questions and answers

How many FDA recalls has OMNIlife science Inc. had?

11 enforcement events (16 product records) on this register, 2014–2020: 11 device.

Are any OMNIlife science Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are OMNIlife science Inc. recalls?

11 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.