Exactech Shoulder Implant Liners Recalled for Defective Oxygen Barrier Packaging
Exactech has recalled 591 units of Equinoxe Reverse Shoulder humeral liners because the packaging lacks a required oxygen barrier layer (EVOH). The nonconforming packaging may affect material integrity of these surgical implants.
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 an FDA Class II medical device recall. Although no illnesses or injuries have been reported, the nonconforming packaging—lacking a required oxygen barrier layer—presents a risk of material degradation in an implanted orthopedic device. Per the rubric, this fits 'risk-of-harm products where injury has not yet been reported,' warranting a High severity score.
Plain-English summary
Exactech, Inc. is recalling 591 units of Equinoxe Reverse Shoulder 46mm Constrained Humeral Liners used in shoulder replacement surgery. These orthopedic implants are manufactured from ultra-high-molecular-weight polyethylene (UHMWPE).
The recall is due to defective packaging. The affected liners were packaged in vacuum bags that do not meet the established packaging specification because they lack an oxygen barrier layer composed of Ethylene Vinyl Alcohol (EVOH). The packaging specification requires this oxygen barrier to protect the material integrity of the implants.
The affected devices were distributed in the United States and internationally to Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, the Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, and Thailand.
The recall affects two configurations: Item 320-46-10 (UDI/DI 10885862086754) and Item 320-46-13 (UDI/DI 10885862086761). Specific affected serial numbers are listed in the FDA recall documentation.
The recalled product
- Product
- Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
- Manufacturer
- Exactech, Inc.
- Affected units
- 591
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 320-46-10
- UDI/DI 10885862086754
- Serial Numbers: 0984536
- 0984533
- 0984546
- 1018089
- 1018095
- 1018091
- 1018097
- 1018084
- 0984530
- 0984547
- 0984529
- 0984532
- 1332742
- 1361390
- 1545622
- 1545624
- 1361388
- 1466508
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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