Exactech Equinoxe Shoulder Implants Recalled for Nonconforming Packaging
Exactech is recalling 245 units of shoulder implants due to nonconforming packaging that lacks a required oxygen barrier layer. The devices were distributed nationwide and internationally.
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 recall of an implantable orthopedic device with no reported injuries or illnesses. It meets the rubric criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Exactech, Inc. is recalling 245 units of Equinoxe Glenoid Posterior Augment shoulder arthroplasty implants. These implants are composed of ultra-high molecular weight polyethylene (UHMWPE) components used in shoulder replacement procedures.
The recalled implants were packaged in vacuum bags that do not meet established specifications. The packaging lacks an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH), which is required to prevent oxidation of the UHMWPE material. Without this barrier, the implant material could degrade, potentially compromising device durability and performance.
The affected implants were 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 facilities should identify and quarantine any recalled Equinoxe Glenoid implants using the serial numbers provided by Exactech and the FDA. Hospitals should discontinue use of affected devices and contact Exactech or the FDA for guidance on device replacement or return procedures.
The recalled product
- Product
- Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-32, b) 41, 44, 47, 50 head, Medium, Item Number314-06-33, c) 44, 47, 50, 53 head, Large, Item Number 314-06-34, d) 44…
- Manufacturer
- Exactech, Inc.
- Affected units
- 245
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 314-06-32
- UDI/DI 10885862228345
- Serial Numbers: 2665747
- 2694660
- 2694664
- 2665744
- 2618441
- 2694656
- 2618425
- 2694647
- 2811847
- 3755779
- 2816627
- 2823580
- 5654258
- 5561037
- 5369535
- 5531306
- 6251869
- 5654254
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.
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