Exactech Shoulder Implant Components Recalled for Nonconforming Oxygen Barrier Packaging
Exactech Inc. is recalling 6,678 shoulder glenoid implant components because they were packaged in vacuum bags lacking the required oxygen barrier layer made of Ethylene Vinyl Alcohol (EVOH).
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II medical device recall with a packaging defect and no reported illnesses, injuries, or deaths. The missing oxygen barrier represents a precautionary concern for device material integrity, but actual clinical impact is unconfirmed and the issue is fundamentally a regulatory compliance matter.
Plain-English summary
Exactech Inc. is recalling Equinoxe GLENOID shoulder arthroplasty components. The affected products include three size variants (small, medium, and large) manufactured for shoulder replacement surgery. Approximately 6,678 units were distributed nationwide and internationally to countries including Canada, Austria, Australia, Brazil, and others.
The packaging of these components is nonconforming and does not meet established specifications. The devices were packaged in vacuum bags that did not contain an additional oxygen barrier layer made of Ethylene Vinyl Alcohol (EVOH). This barrier layer is a required component of the manufacturer's packaging specification.
Patients who have received these implants or healthcare providers with affected inventory should contact Exactech Inc. for guidance. The company is providing information about replacements and remedial actions.
The recalled product
- Product
- Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
- Manufacturer
- Exactech, Inc.
- Affected units
- 6,678
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 314-02-02
- UDI/DI 10885862084477
- Serial Numbers: 0747871
- 0747855
- 0747853
- 0747858
- 0747827
- 0747805
- 0747814
- 0747845
- 0747781
- 0747779
- 0747823
- 0747835
- 0747804
- 0747813
- 0747839
- 0747775
- 0747838
- 0747798
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 24 products in this recall →Related recalls
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Similar recalls
- HighExactech Equinoxe Shoulder System recalled for loss of vacuum
FDA (Devices) · 2023-12-27
- ModerateExactech Recalls 30 Mislabeled Equinoxe Shoulder Implant Components
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