Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, 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, 12o, LEFT, FOR CEMENTED USE 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-1408-2024
Action Date
2024-04-10
Status
Ongoing
Category
device
Product Description
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-23, c) 44, 47, 50, 53 head, Large, Item Number 314-04-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-25; Shoulder Arthroplasty
Lot/Code Info: a) Item Number 314-04-22, UDI/DI 10885862199553, Serial Numbers: 2111946, 2136867, 2136870, 2427405; b) Item Number 314-04-23, UDI/DI 10885862199560, Serial Numbers: 2111953, 2111954, 2139294, 2111955, 2139292, 2139291, 2139288, 2139290, 2424307, 2424304, 2111952, 2424306, 2424314, 2424305, 2482942; c) Item Number 314-04-24, UDI/DI 10885862199577, Serial Numbers: 2111949, 2111950, 2153613, 2153608, 2153607, 2153611, 2153612, 2421997, 2153609, 2421992, 2111951, 2153610, 2421994; d) Item Number 314-04-25, UDI/DI 10885862199584, Serial Numbers: 2112018, 2112019, 2427567
Quantity Affected: 35 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
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-1408-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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