Exactech Shoulder Implant Components Recalled for Inadequate Oxygen Barrier Packaging
Exactech Equinoxe shoulder implant components (4,007 units) are recalled because their vacuum-sealed packaging lacks a required oxygen barrier layer, potentially allowing material degradation.
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: Class II recall involving packaging defect on an orthopedic implant device without reported illnesses or injuries. Missing oxygen barrier layer creates risk of UHMWPE material degradation, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Exactech, Inc. is recalling approximately 4,007 units of Exactech Equinoxe shoulder implant glenoid components distributed nationwide and internationally. These UHMWPE (ultra-high-molecular-weight polyethylene) components are used in shoulder replacement surgeries.
The recalled units have nonconforming packaging that does not meet established specifications. The components were packaged in vacuum bags without an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). Without this barrier, oxygen exposure may occur, potentially degrading the UHMWPE material.
Affected individuals and healthcare providers should refer to the FDA's official recall notice for the complete list of affected serial numbers and take appropriate action.
The recalled product
- Product
- Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head…
- Manufacturer
- Exactech, Inc.
- Affected units
- 4,007
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 314-13-32
- UDI/DI 10885862201003
- Serial Numbers: 3864654
- 3864659
- 4140193
- 4155690
- 4257179
- 4250984
- 4155679
- 4140217
- 4155678
- 3864658
- 4108679
- 4155704
- 4257186
- 4257198
- 3926702
- 4108676
- 4257194
- 4108680
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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FDA (Devices) · 2023-12-27
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