Wright Medical Recalls Dart Fire Headed Screws Due to Sterility Documentation Issues
Wright Medical Technology is recalling 77 units of Dart Fire Headed Screws because the firm discovered a lack of adequate documentation confirming sterility.
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, but the source text explicitly states the issue is a lack of documentation confirming sterility, with no reported illnesses or injuries. This aligns with the rubric for moderate severity involving documentation issues or theoretical risks without reported harm.
Plain-English summary
Wright Medical Technology, Inc. is recalling 77 units of Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S. The recall was initiated after the firm discovered a lack of adequate documentation confirming sterility on certain products.
The affected products are identified by Lot Number 1555125. These medical devices were distributed in the US and in Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, and Spain.
Consumers and healthcare providers should stop using the affected products and contact Wright Medical Technology for further instructions.
The recalled product
- Product
- Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- Affected units
- 77
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 1555125
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.
See all 12 products in this recall →Related recalls
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