Wright Medical Recalls Sterile Headed Drill Bits Due to Documentation Issues
Wright Medical Technology is recalling 66 units of sterile headed drill bits because documentation confirming sterility was inadequate.
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 2/5 (Moderate).
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 and involves a documentation issue regarding sterility confirmation without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Wright Medical Technology, Inc. is recalling 66 units of the Darco STERILE HEADED DRILL BIT 4.4MM (Part Number 777S06514, Lot Number 1555781). The recall was initiated after the firm discovered a lack of adequate documentation confirming the sterility of these specific products.
The affected products were distributed in the United States and internationally, including Norway, Italy, Germany, France, South Africa, the UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, and Spain. The source text does not specify the exact number of units distributed in each location.
Consumers and healthcare providers should stop using the affected drill bits and contact Wright Medical Technology for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- Affected units
- 66
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)
- Lot Number 1555781
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 12 recalled by Wright Medical Technology, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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