Exactech shoulder implant components recalled for nonconforming packaging
Exactech is recalling 805 Equinoxe glenoid implant components due to nonconforming vacuum packaging that lacks required oxygen barrier protection, which could affect sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for medical device with nonconforming packaging that could compromise sterility of a surgical implant. No illnesses or injuries reported, but the defect represents a potential risk to patient safety.
Plain-English summary
Exactech, Inc. is recalling 805 Equinoxe glenoid components used in shoulder arthroplasty. These are posterior augment glenoids available in small, medium, large, and extra-large sizes in left shoulder configuration.
The recalled components have nonconforming packaging. They were packaged in vacuum bags that do not meet the established specification because they lack an additional oxygen barrier layer made of Ethylene Vinyl Alcohol (EVOH). This missing barrier could compromise product sterility.
The affected components were distributed nationwide in the United States and internationally to 28 countries including 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, and Thailand.
The recalled product
- Product
- Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 hea
- Manufacturer
- Exactech, Inc.
- Hazard
- packaging-defect
- sterility-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) Item Number 314-02-22
- UDI/DI 10885862175052
- Serial Numbers: 1984576
- 1984575
- 2090821
- 1984570
- 1984581
- 1984569
- 2090824
- 2093611
- 2090832
- 2090825
- 2379003
- 2090861
- 2090820
- 1984577
- 2090843
- 2378999
- 2379029
- 2425682
Distribution
Distributed nationwide across the United States.
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