Ilizarov Wire Tensioner Recalled Due to Manufacturing Defect
Medicalplastic S.R.L. is recalling Ilizarov Wire Tensioners (Model 71070341) due to an internal washer made of incorrect material. The washer could wear and break during autoclave sterilization, causing the tensioner to malfunction.
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: No illnesses or injuries have been reported. However, the manufacturing defect creates a direct risk that the medical device could malfunction during use, meeting the criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Medicalplastic S.R.L. is recalling Ilizarov Wire Tensioners, Model 71070341, due to a manufacturing error affecting the internal washer. The washer was made from an incorrect plastic material and could wear and break during autoclave sterilization, potentially causing the tensioner to malfunction.
The recall involves approximately 581 units distributed to Memphis, TN. Affected lot and serial numbers are specified in the original recall documentation. Medicalplastic S.R.L. is conducting a voluntary field action to remove these devices from use.
The recalled product
- Product
- Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
- Manufacturer
- Medicalplastic S.R.L.
- Category
- Medical Device
- Affected units
- 581
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)
- Lot # 20LP02813
- Serial #D147 to D149
- Lot # 20LP02812
- Serial # D115 to D119
- Lot # 20LP02816
- Serial # D099 to D114
- Lot # 20HP01926
- Serial # D059 to D065
- Lot # 20LP02819
- Serial # D175 to D198
- Lot # 20LP02818
- Serial # D129 to D146
- Lot # 20LP02815
- Serial # D120 to D128
- Lot # 20MP03078
- Serial # D374
- Lot # 20HP01927
- Serial # D278 to D282
- Lot # 20MP03037
- Serial # D294 to D296
Distribution
Distributed in 1 state:
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