Exactech Orthopedic Surgical Tool Recalled for Fracture Risk
Exactech is recalling 41 GPS Total Shoulder Application 3.2mm Vix Bits because they may fracture during use.
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: The recall is classified as FDA Class II and involves a risk of harm (fracture during use) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Exactech, Inc. is recalling 41 units of the GPS Total Shoulder Application 3.2mm Vix Bit, an orthopedic surgical tool. The recall is being conducted because the Vix Bit may fracture during use.
The affected devices are identified by Catalog No. 531-15-08 and Lot Nos. 75296003, 80129003, and 81327001. These products were distributed worldwide, including in the US states of Florida and California, as well as in Australia, France, Spain, and the United Kingdom.
The U.S. Food and Drug Administration has classified this as a Class II recall. No specific instructions for consumers are provided in the source text, but the risk of the tool fracturing during a surgical procedure presents a potential hazard.
The recalled product
- Product
- Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 41
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 (4)
- Catalog No. 531-15-08
- Lot No. 75296003
- 80129003
- 81327001
Distribution
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