Exactech Equinoxe shoulder arthroplasty glenoid components recalled for packaging defects
Exactech is recalling 35 units of Equinoxe shoulder arthroplasty glenoid components because packaging lacks required oxygen barrier protection. The components were packaged in vacuum bags without Ethylene Vinyl Alcohol (EVOH) layers.
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 with no reported hospitalizations or injuries. The defect involves nonconforming packaging—missing oxygen barrier layer—which represents a risk-of-harm situation for an implanted medical device where injury has not yet been reported, meeting the rubric criteria for Score 3 (High).
Plain-English summary
Exactech, Inc. is recalling 35 units of Equinoxe glenoid components used in shoulder arthroplasty procedures. These posterior-augmented, pegged components are available in four sizes and are intended for cemented use only.
The recall was initiated because the components' packaging does not meet specifications. The vacuum bags used for packaging were missing a required additional oxygen barrier layer made of Ethylene Vinyl Alcohol (EVOH).
The affected units have been distributed nationwide across the United States and to numerous countries including 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.
The recalled product
- Product
- Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-23, c) 44, 47, 50, 53 head, Large, Item Number 314-04-24, d) 44…
- Manufacturer
- Exactech, Inc.
- Affected units
- 35
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 314-04-22
- UDI/DI 10885862199553
- Serial Numbers: 2111946
- 2136867
- 2136870
- 2427405
- b) Item Number 314-04-23
- UDI/DI 10885862199560
- Serial Numbers: 2111953
- 2111954
- 2139294
- 2111955
- 2139292
- 2139291
- 2139288
- 2139290
- 2424307
- 2424304
- 2111952
- 2424306
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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