Steris Recalls Fine Traction Devices Due to Bearing Defect
Steris Corporation is recalling 16 units of Fine Traction Devices because a bearing failed pre-release reliability testing. The devices were distributed in five US states and Canada.
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 is classified as FDA Class II, and the source text describes a mechanical defect (bearing failure) in a medical device used during surgery. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as no specific injuries or illnesses are mentioned in the source text.
Plain-English summary
Steris Corporation is recalling 16 units of the STERIS Fine Traction Device. This medical device is used to provide traction and enable fine adjustments to the orientation of the leg during orthopedic procedures. The recall involves specific serial numbers listed in the agency documentation.
The recall was initiated because a bearing used in the assembly of the device did not perform successfully in pre-release reliability testing. Although a replacement bushing passed testing and was authorized for use via a change order, the new part was inadvertently not implemented in the affected units.
The affected product was distributed nationwide in the United States, specifically in Colorado, Kentucky, Louisiana, Virginia, and Wisconsin, as well as to Canada. Consumers and healthcare facilities should stop using the affected devices and contact Steris Corporation for instructions on replacement or return.
The recalled product
- Product
- STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures.
- Manufacturer
- Steris Corporation
- Affected units
- 16
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 (20)
- The following serial/lot numbers are affected by this recall: 0404913150
- 0404913151
- 0404913152
- 0404913153
- 0408713001
- 0408713002
- 0408713003
- 0408713004
- 0408713005
- 0408713006
- 0409813097
- 0409813098
- 0409813099
- 0409813100
- 0410113001
- 0410113002
- 0410713024
- 0410713025
- 0410713026
- 0410713027
Distribution
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