Exactech Equinoxe Reverse Shoulder Implants Recalled for Nonconforming Packaging
Exactech is recalling 826 Equinoxe Reverse Shoulder humeral liners (Item Numbers 320-36-10 and 320-36-13) due to nonconforming packaging. The vacuum bags lack the required oxygen barrier layer consisting 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 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: Medical implant classified as risk-of-harm product (shoulder arthroplasty implant) with packaging specification defect affecting device preservation. Although no illnesses or injuries have been reported, the safety-critical nature of the missing oxygen barrier meets the high-severity rubric criterion for risk-of-harm products without yet-reported adverse events.
Plain-English summary
Exactech, Inc. is recalling 826 units of the Equinoxe REVERSE SHOULDER 36mm Constrained Humeral Liner (Item Numbers 320-36-10 and 320-36-13) due to packaging that does not meet the established packaging specification.
The packaging defect involves the absence of an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). The recalled devices were packaged in vacuum bags that lack this required barrier.
The affected products were distributed nationwide in the United States and internationally to Austria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, and Thailand. Patients and healthcare providers with affected implants should contact Exactech, Inc. for further guidance regarding appropriate follow-up.
The recalled product
- Product
- Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
- Manufacturer
- Exactech, Inc.
- Affected units
- 826
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 320-36-10
- UDI/DI 10885862086631
- Serial Numbers: 2608259
- 2878175
- 3759662
- 3759663
- 3810144
- 3810149
- 3786337
- 3872525
- 3872529
- 3872524
- 3872528
- 3872526
- 3872520
- 3872535
- 3872523
- 3872539
- 3872521
- 3872534
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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