Exactech Equinoxe shoulder components recalled for nonconforming packaging
Exactech is recalling 2,008 Equinoxe shoulder implant components due to packaging that lacks a required oxygen barrier layer. The defect does not meet product 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 recall involving a packaging defect that does not meet product specifications. The nonconforming packaging of implantable orthopedic components presents a risk-of-harm scenario where oxidative degradation of UHMWPE material could occur, though no illnesses or injuries have been reported to date.
Plain-English summary
Exactech, Inc. is recalling 2,008 units of Equinoxe GLENOID, KEELED, CEMENTED shoulder arthroplasty components across three sizes. The affected components include small, medium, and large variants with specific item numbers and serial numbers.
The recalled components have nonconforming packaging. The units were packaged in vacuum bags that do not include a required oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH), contrary to the established product packaging specification.
The affected components were distributed nationwide and internationally, with distribution to multiple countries across North America, Europe, Asia, and other regions.
Healthcare facilities and distributors that have received these components should verify whether their inventory contains any of the affected serial numbers and contact Exactech, Inc. for instructions regarding remedial actions.
The recalled product
- Product
- Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
- Manufacturer
- Exactech, Inc.
- Affected units
- 2,008
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 314-01-12
- UDI/DI 10885862084439
- Serial Numbers: 0744170
- 0756603
- 0744142
- 0744169
- 0744178
- 0744141
- 0744152
- 0744182
- 0756566
- 0756592
- 0756611
- 0744134
- 0744135
- 0756591
- 0744177
- 0756567
- 0756582
- 0756606
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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Similar recalls
- ModerateExactech Recalls 30 Mislabeled Equinoxe Shoulder Implant Components
FDA (Devices) · 2018-02-07
- ModerateExactech Recalls 30 Equinoxe Shoulder Implants Due to Mislabeling
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