Food, drugs, devices › Omnilife Science Inc.

Device recall: Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral comp

FDA enforcement event 71407 · Class II · initiated 3 Jun 2015 · status Terminated · terminated 8 Sep 2015

DeviceVoluntary: Firm initiated1 product recordEast Taunton, MA

Omnilife Science Inc. (East Taunton, MA) initiated this device recall on 3 Jun 2015; FDA lists 1 product record under event 71407, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 8 Sep 2015. Initiation: voluntary: firm initiated. Omnilife Science Inc. has 11 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Omnilife Science Inc., East Taunton, MA.

Reason for recall

"Product may breach the inner and outer sterile pouches during shipping or handling."

Distribution

"US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2064-2015	Apex 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.…	146 devices	Class II	Terminated	22 Jul 2015

Context

91%of 2015 device events are Class II1,153 events that year

1product record in this eventfirm median: 1

11events on this register for the firm

Other enforcement events for Omnilife Science Inc.

Initiated	Product (first record)	Type	Class	Records
21 Dec 2020	SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup fo	Device	Class II	3
11 Sep 2019	OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or	Device	Class II	1
23 Jul 2019	OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code:	Device	Class II	3
12 Apr 2019	OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel sur	Device	Class II	1
29 Nov 2018	OMNI K1 Broach Handle, Product Code HS-10054	Device	Class II	1
18 May 2018	OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product	Device	Class II	1
20 Nov 2017	Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a prim	Device	Class II	1
9 Jun 2015	Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to	Device	Class II	2
4 Jun 2015	APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Int	Device	Class II	1
9 May 2014	Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA	Device	Class II	1

All 11 events for Omnilife Science Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Product may breach the inner and outer sterile pouches during shipping or handling."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 8 Sep 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.