Exactech Equinoxe Shoulder Implants Recalled Due to Nonconforming Oxygen Barrier Packaging
Exactech is recalling 7,213 units of Equinoxe REVERSE SHOULDER prosthetic liners due to nonconforming packaging. The vacuum bags lack the required oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH) specified for these devices.
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 medical device recall affecting orthopedic implants with nonconforming packaging and no reported illnesses or injuries. This constitutes a risk-of-harm product where injury has not yet been reported, meeting the severity rubric criterion for High (3).
Plain-English summary
Exactech Inc. has recalled 7,213 units of Equinoxe REVERSE SHOULDER Constrained Humeral Liners (Item Numbers 320-38-10 and 320-38-13) used in shoulder arthroplasty procedures. The affected devices were packaged in vacuum bags that do not meet the established packaging specification because they lack the required oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
The recalled prosthetic components have been distributed nationwide in the United States and internationally to Australia, Austria, Belgium, Brazil, Chile, Canada, 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.
Healthcare providers and patients who have received these devices should verify whether their implants are among those recalled by checking the comprehensive list of affected serial numbers. Consumers with questions or concerns about specific devices should contact Exactech, Inc. for further information and guidance regarding their implants.
The recalled product
- Product
- Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
- Manufacturer
- Exactech, Inc.
- Affected units
- 7,213
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 320-38-10
- UDI/DI 10885862086679
- Serial Numbers: 0982088
- 0982095
- 1035622
- 0982086
- 1035885
- 0982078
- 1035878
- 1035894
- 1036369
- 1036373
- 1013872
- 1013887
- 1035623
- 1035875
- 1035880
- 1035881
- 1035883
- 1119110
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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