Exactech Equinoxe Reverse Shoulder Humeral Liners Recalled for Dimensional Defect
Exactech is recalling Equinoxe Reverse Shoulder Humeral Liners due to articular surface positioning outside manufacturing specifications. Approximately 61,334 units distributed worldwide may be affected.
What this means for you
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 a Class II medical device recall affecting a surgical implant with a dimensional specification defect that could affect device function. No injuries or hospitalizations are reported in the source text, but the product presents a potential risk of harm.
Plain-English summary
Exactech, Inc. is recalling Equinoxe Reverse Shoulder Humeral Liners due to a manufacturing defect. The articular surface position on the recalled liners is outside the dimensional specifications stated in the device labeling.
Approximately 61,334 units have been distributed worldwide, including to healthcare facilities across the United States and in international locations. The recall affects multiple product references: 320-38-00, 320-38-03, 320-42-00, and 320-42-03. All serial numbers of these products are included in the recall.
Patients who have received this device should consult their surgeon or healthcare provider about their individual situation. Healthcare providers seeking information about the recall should contact Exactech, Inc. directly.
The recalled product
- Product
- Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/
- Manufacturer
- Exactech, Inc.
- Hazard
- dimensional-defect
- device-malfunction
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 (1)
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
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