Z-1408-2024 Class II Ongoing
FDA device recall Z-1408-2024 was initiated by Exactech, Inc. on Mar 6, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 35 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 10, 2024
- Initiation Date
- Mar 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 units
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
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 Pattern
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
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1408-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026