Exactech Equinoxe Glenoid Shoulder Components Recalled for Nonconforming Packaging
Exactech, Inc. is recalling 2,077 units of Equinoxe Glenoid shoulder components due to nonconforming packaging. The affected units were packaged in vacuum bags lacking the required oxygen barrier layer.
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: FDA Class II recall for orthopedic implant components with a packaging specification defect that could potentially affect long-term device performance. No adverse events or injuries have been reported at this time.
Plain-English summary
Exactech, Inc. is recalling 2,077 units of Equinoxe Glenoid shoulder replacement components in three sizes (small, medium, and large) due to packaging defects. The affected components have been distributed nationwide and internationally.
The affected glenoid components were packaged in vacuum bags that do not meet established packaging specifications. Specifically, the packaging lacks a required oxygen barrier layer containing Ethylene Vinyl Alcohol (EVOH), which is designed to protect the components during storage and transport.
Patients who have received these shoulder components should contact their surgeon or healthcare provider. Healthcare facilities and surgeons that received affected inventory should immediately stop using these units and contact Exactech for instructions regarding replacement or monitoring of implanted devices.
The recalled product
- Product
- Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 2,077
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 314-01-02
- UDI/DI 10885862084408
- Serial Numbers: 0745683
- 0747928
- 0745666
- 0747961
- 0747950
- 0747985
- 0747941
- 0747948
- 0745671
- 0745675
- 0747921
- 0745670
- 0747929
- 0747944
- 0747995
- 0748000
- 0745681
- 0747932
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
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