Exactech Equinoxe Humeral Stem Recalled for Incorrect Packaging Instructions
Exactech is recalling 40 Equinoxe Preserve Humeral Stems because they may have been packaged with instructions for a different knee implant.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a packaging and documentation issue (incorrect instructions for use) with no reported injuries or adverse health consequences.
Plain-English summary
Exactech, Inc. is recalling 40 units of the Equinoxe Preserve Humeral Stem, 8mm, due to a packaging error. The devices may have been inadvertently packaged with the instructions for use (IFU) for the Optetrak Knee System rather than the correct IFU for the Equinoxe Preserve Humeral Stem.
The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint. The affected devices were distributed nationwide in the states of Alabama, Florida, Iowa, Louisiana, Maryland, Ohio, and South Carolina.
Healthcare providers and patients should verify that the instructions for use match the specific implant model. If the incorrect instructions were used, providers should consult the correct Equinoxe Preserve Humeral Stem IFU for proper usage guidelines.
The recalled product
- Product
- Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty,anatomic hemi-arthroplasty,or reverse total…
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 40
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 (10)
- Catalog Number: 300-30-08
- UDI: 10885862515766
- Serial Numbers: 5569566
- 5569576
- 5569579
- 5569582
- 5569584
- 5569586
- 5569589
- 5569595.
Distribution
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