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OMNIlife science Inc.

Complete recall history across all FDA and CPSC categories — 16 total recalls

OMNIlife science Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (16)

FDA medical device enforcement actions by OMNIlife science Inc.

Date Product Reason Class
Dec 21, 2020 SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for ... Acetabular Liners have a higher than acceptable oxidation limit, potential fo... Class II
Dec 21, 2020 SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for ... Acetabular Liners have a higher than acceptable oxidation limit, potential fo... Class II
Dec 21, 2020 SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for u... Acetabular Liners have a higher than acceptable oxidation limit, potential fo... Class II
Sep 11, 2019 OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended f... Stems missing porous coating on the device. Class II
Jul 23, 2019 OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ... Acetabular liners failed the oxidation testing performed prior to release. Th... Class II
Jul 23, 2019 OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ... Acetabular liners failed the oxidation testing performed prior to release. Th... Class II
Jul 23, 2019 OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ... Acetabular liners failed the oxidation testing performed prior to release. Th... Class II
Apr 12, 2019 OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iB... The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide a... Class II
Nov 29, 2018 OMNI K1 Broach Handle, Product Code HS-10054 There is a potential for the inner pin of the handle to become loose and fall... Class II
May 18, 2018 OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product C... The Internal packaging, the pouch and patient labels are improperly labeled. Class II
Nov 20, 2017 Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The ... The Apex Knee System Tibial Baseplate identified has an improper expiration d... Class II
Jun 9, 2015 Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product U... The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are inco... Class II
Jun 9, 2015 Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Us... The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are inco... Class II
Jun 4, 2015 APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-1... The device may have improper screw hole placement due to inaccurate location ... Class II
Jun 3, 2015 Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Us... Product may breach the inner and outer sterile pouches during shipping or han... Class II
May 9, 2014 Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA Staining on hip implant. Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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