Class II Recall

Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47

Summary

The FDA issued a Class II for Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED US by Exactech, Inc.. Reason: The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They.

Details

Source

Device Recall

External ID

Z-1411-2024

Action Date

2024-04-10

Status

Ongoing

Product Description

Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-32, b) 41, 44, 47, 50 head, Medium, Item Number314-06-33, c) 44, 47, 50, 53 head, Large, Item Number 314-06-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-06-35; Shoulder Arthroplasty

Lot/Code Info: a) Item Number 314-06-32, UDI/DI 10885862228345, Serial Numbers: 2665747, 2694660, 2694664, 2665744, 2618441, 2694656, 2618425, 2694647, 2811847, 3755779, 2816627, 2823580, 5654258, 5561037, 5369535, 5531306, 6251869, 5654254, 6602367, 6602371, 5654267, 6602366, 6602372, 6251862, 6602374, 6602375, 6602376, 6236784, 6236780; b) Item Number 314-06-33, UDI/DI 10885862228352, Serial Numbers: 2618447, 2618463, 2694637, 2694643, 2618457, 2694624, 2694628, 2816683, 2694627, 2694635, 2816669, 2618455, 3825300, 2823610, 2816679, 2816676, 2823603, 2694641, 2823600, 2665755, 2618460, 2618462, 3755793, 4209645, 2823598, 2694644, 2823595, 2816680, 2816667, 2694642, 2823602, 2816657, 2811751, 2823609, 2816675, 2811760, 3825299, 4209641, 2823605, 2816666, 2816670, 3825291, 2811758, 5305335, 5305330, 5551792, 3825294, 3825307, 4209638, 4209646, 5368875, 5590110, 5933303, 5933313, 5305329, 6195013, 5654283, 6195012, 5305332, 5305314, 5305322, 5551790, 5305337, 6195312, 5933316, 6195317, 6520942, 6520949, 6190106, 6190096, 6190099, 6190109, 6520940, 6520948, 6520936; c) Item Number 314-06-34, UDI/DI 10885862228369, Serial Numbers: 2618486, 2618479, 2618468, 2694559, 2694548, 2694544, 2816686, 2694555, 2618469, 2665763, 2618475, 2665760, 2665757, 2618474, 2618484, 2694553, 2816705, 2816701, 2816704, 2694551, 2694560, 2618476, 2618482, 2665764, 2816706, 2811794, 2823616, 4209654, 2816719, 3856956, 4209663, 2816692, 2811786, 4209656, 2694558, 2816709, 4209664, 2811778, 2694556, 2823620, 2816703, 2694543, 2816690, 4209666, 2823618, 4209669, 2694546, 2823626, 3856953, 2823628, 2823634, 2816712, 2811792, 2823614, 2816696, 2816687, 2811787, 4209661, 2823617, 5305873, 4811744, 4854990, 5305881, 4793714, 5305872, 5272949, 5305870, 5554843, 5554845, 3794406, 3755777, 3856954, 5305894, 5305888, 5753656, 5679293, 5579557, 5554832, 5753642, 5753638, 5369538, 5369540, 5753637, 5305883, 5305892, 5305886, 5554846, 6051510, 6718721, 6718722, 6718718, 6718723, 6718736, 6143299, 6143293, 6143295, 6051513, 5753636, 6051495, 6051583, 6051584, 6718731, 6718732, 5679292, 5753643, 5753650, 6143300, 6143307, 6718726, 6718733; d) Item Number 314-06-35, UDI/DI 10885862228376, Serial Numbers: 2618496, 2618503, 2694849, 2618502, 2618500, 2694863, 2816720, 2816749, 2694861, 2694867, 2694854, 2618489, 2694865, 2811816, 2816733, 2618492, 2823637, 2816742, 4209677, 3755785, 5730064, 3882605, 4209672, 5369463, 6372776, 6372771, 6372775, 6372770, 6372772, 6372778, 6372787

Quantity Affected: 245 units

Reason for Recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Distribution

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

Type: Voluntary: Firm initiated

Recall Initiated: 2024-03-06

Company

Exactech, Inc.

Gainesville, FL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Exactech, Inc. has 110 FDA actions in our database, including 97 recalls and 13 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Exactech, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Exactech, Inc. have FDA actions?

Exactech, Inc. has 110 FDA actions in our database, including 97 recalls and 13 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1411-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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