Acumed Orthopedic Guide Wires Recalled Due to Packaging Errors
Acumed LLC is recalling specific lots of .045 and .054 orthopedic guide wires because they were mis-packaged with incorrect size labels.
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 3/5 (High).
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 involves a risk-of-harm medical device where potential injuries such as malunion and revision surgery are described, but no specific reported injuries or illnesses are mentioned in the source text.
Plain-English summary
Acumed LLC is recalling 24 units of .045 X 6 ST Guide Wires (Lot 391681) and 25 units of .054 X 7 ST Guide Wires (Lot 391680). These orthopedic manual surgical instruments were distributed worldwide in Great Britain, Ireland, and Japan.
The recall was initiated because the guide wires were mis-packaged; .045 X 6 wires were labeled as .054 X 7, and .054 X 7 wires were labeled as .045 X 6. Using the incorrect guide wire size can cause health hazards, including mal or nonunion, the need for revision surgery, and histological response if the wire breaks.
Healthcare providers and facilities that have received these specific lots should stop using the affected guide wires and contact Acumed LLC for instructions on how to return or dispose of the products.
The recalled product
- Product
- .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are…
- Manufacturer
- Acumed LLC
Distribution
Distribution scope not specified by the agency.
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