Exactech Equinoxe Reverse Shoulder Humeral Liners dimensional specification recall
Exactech Equinoxe Reverse Shoulder Humeral Liners are being recalled because the articular surface position is outside dimensional specifications in certain units distributed worldwide.
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 an FDA Class II medical device recall. The dimensional specification deviation constitutes a risk-of-harm scenario on an orthopedic implant component. Per the rubric, risk-of-harm products where injury has not yet been reported receive a High severity score.
Plain-English summary
Exactech, Inc. is recalling Exactech Equinoxe Reverse Shoulder Humeral Liners due to dimensional specification deviation. The articular surface position of the affected units falls outside the dimensional specifications provided in the product labeling.
The affected products include four specific reference numbers: 322-38-00, 322-38-03, 322-42-00, and 322-42-03. A total of 11,542 units have been distributed worldwide, including across the United States and internationally in Australia, Austria, Brazil, Canada, Colombia, France, the United Kingdom, Guatemala, India, Italy, Japan, Korea, Germany, the Netherlands, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, and Dubai.
Patients who have received these liners should consult with their surgeon or contact Exactech directly with any questions or concerns regarding their implant.
The recalled product
- Product
- Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)
- Manufacturer
- Exactech, Inc.
- Hazard
- dimensional-specification-deviation
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 (5)
- All Serial Numbers
- REF: 322-38-00/UDI:10885862593832
- REF: 322-38-03/UDI:10885862593849
- REF: 322-42-00/UDI: 10885862593917
- REF:322-42-03/UDI:10885862593924
Distribution
Distributed nationwide across the United States.
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