Exactech Recalls InteGrip Acetabular Augments Due to Biological Evaluation Failure
Exactech is recalling 235 units of InteGrip Acetabular Augments because an in-vitro biological evaluation standard was out of range.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries are reported and the hazard is a theoretical out-of-range condition for an in-vitro standard, fitting the criteria for a voluntary precautionary recall or low-risk contamination.
Plain-English summary
Exactech, Inc. is recalling 235 units of the InteGrip Acetabular Augments. These medical devices are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip replacement, specifically as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.
The recall was initiated due to an out-of-range condition for an in-vitro biological evaluation standard. The affected units were distributed in the United States, including the states of Florida, Virginia, New York, Ohio, Maine, Texas, Colorado, and Georgia.
The source text does not specify instructions for consumers or healthcare providers regarding the handling of these devices. No illnesses or injuries are reported in the provided text.
The recalled product
- Product
- ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip
- Manufacturer
- Exactech, Inc.
- Affected units
- 235
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 (15)
- Catalog Numbers: 186-01-08
- 186-01-11
- 186-01-13
- 186-02-08
- 186-02-11
- 186-02-13
- 186-03-11
- 186-03-08
- 186-03-13
- 186-04-08
- 186-04-11
- 186-04-13
- 186-05-08
- 186-05-11
- 186-05-13.
Distribution
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