Exactech Equinoxe Shoulder Components Recalled for Packaging Defect
Exactech is recalling 6,840 units of Equinoxe shoulder implant components because their vacuum packaging lacks the required oxygen barrier layer (EVOH). The defect could potentially allow material degradation during storage.
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 3/5 (High).
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: This is a risk-of-harm product (implanted orthopedic component) where material degradation is possible due to improper packaging. Although no injuries have been reported, the lack of the required oxygen barrier layer creates a credible risk that the UHMWPE material could degrade during storage, potentially affecting implant integrity and performance.
Plain-English summary
Exactech, Inc. is recalling 6,840 units of Equinoxe shoulder implant components due to nonconforming packaging. The affected products include glenoid (socket) and humeral liner components in small, medium, large, and extra-large sizes, distributed nationwide and internationally.
The affected units were packaged in vacuum bags that do not contain the required Ethylene Vinyl Alcohol (EVOH) oxygen barrier layer. This packaging does not meet the established specification for these devices.
The products were distributed nationwide in the United States and to 29 countries including Australia, Austria, Canada, Germany, Japan, and others. Healthcare facilities and surgeons should check their inventory for affected units using the provided item numbers and serial numbers, and contact Exactech, Inc. for further guidance.
The recalled product
- Product
- Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
- Manufacturer
- Exactech, Inc.
- Affected units
- 6,840
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 314-02-12
- UDI/DI 10885862084507
- Serial Numbers: 0790902
- 0790901
- 0790903
- 0790904
- 0790907
- 0790908
- 0790910
- 0790919
- 0790899
- 0790912
- 0797553
- 0790917
- 0797597
- 0797605
- 0797554
- 0797582
- 0790914
- 0797567
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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