Exactech Equinoxe Shoulder Glenoid Components Recalled for Defective Packaging
Exactech is recalling 985 shoulder implant components due to nonconforming packaging that lacks a required oxygen barrier layer. The vacuum bags do not meet packaging specifications.
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 with no reported illnesses or injuries. The packaging defect—vacuum bags lacking the required Ethylene Vinyl Alcohol (EVOH) oxygen barrier—represents a risk to implant material integrity, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Exactech, Inc. is recalling 985 units of Equinoxe GLENOID POSTERIOR AUGMENT components used in shoulder implant surgery. The affected products are available in four sizes: part numbers 314-02-32 (Small), 314-02-33 (Medium), 314-02-34 (Large), and 314-02-35 (Extra Large).
The packaging of these components does not meet the established specification. The vacuum bags do not contain the required additional oxygen barrier layer of Ethylene Vinyl Alcohol (EVOH).
The affected components have been distributed nationwide in the United States and internationally, including to countries such as Australia, Canada, China, France, Germany, India, Japan, and Spain. Specific serial numbers for each affected component size have been provided for identification purposes.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53…
- Manufacturer
- Exactech, Inc.
- Affected units
- 985
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 314-02-32
- UDI/DI 10885862175052
- Serial Numbers: 2090670
- 1984370
- 2086996
- 2090655
- 2108671
- 2086997
- 2086999
- 2379424
- 2479807
- 2640374
- 2142682
- 2147846
- 2142679
- 2479798
- 2090659
- 2147857
- 2147847
- 2640379
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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