Exactech Equinoxe Reverse Shoulder Humeral Liner Recall Due to Nonconforming Packaging
Exactech is recalling 1,970 Equinoxe Reverse Shoulder humeral liners distributed nationwide and internationally due to nonconforming packaging that lacks required oxygen barrier protection. Affected devices may have compromised sterile barriers.
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 with nonconforming packaging that could compromise sterile integrity. No illnesses or injuries have been reported. Per the rubric, recalls with theoretical hazards and no reported adverse outcomes score at most 3 (High).
Plain-English summary
Exactech, Inc. is recalling 1,970 Equinoxe Reverse Shoulder 46mm humeral liners (Item numbers 320-46-00 and 320-46-03) used in shoulder arthroplasty procedures. The recalled devices were packaged in vacuum bags that do not meet established packaging specifications because they lack a required oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
The oxygen barrier layer is required to protect sterile devices during storage and transport. Vacuum bags lacking this barrier may allow degradation or contamination of the device.
Approximately 1,970 units were distributed nationwide and to over 30 countries including Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Japan, South Korea, and others. Affected devices can be identified by specific serial numbers listed in FDA recall notice Z-1424-2024.
The recalled product
- Product
- Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
- Manufacturer
- Exactech, Inc.
- Affected units
- 1,970
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 320-46-00
- UDI/DI 10885862086730
- Serial Numbers: 0984597
- 0984599
- 0984577
- 0984598
- 0984588
- 0984582
- 0984590
- 0984601
- 1014640
- 0984592
- 0984594
- 1014637
- 1014644
- 1135617
- 1135600
- 1135635
- 1135609
- 1135637
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 vacuum loss in bags
FDA (Devices) · 2023-12-27
- HighShoulder humeral liners recalled over articular surface outside dimensional specification
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