Smith & Nephew Recalls SL Plus Mia Double Offset Adapter Units
Smith & Nephew is recalling 72 units of the SL Plus Mia Double Offset Adapter because a pin may not be properly mounted and could disassemble.
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 involves a mechanical defect that could lead to disassembly, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Smith & Nephew, Inc. is recalling 72 units of the SL Plus Mia Double Offset Adapter Right 60/25MM. The affected units are identified by serial number 75004613 and lot numbers C63165, C63306, and C63495.
The recall is due to a defect where the pin that holds the spring mechanism is not properly mounted. This issue could potentially cause the pin to disassemble. The agency has classified this recall as Class II.
The affected products were distributed in New York, Tennessee, Germany, Italy, Great Britain, and Singapore. Consumers and healthcare providers should stop using the affected units and contact Smith & Nephew for instructions on how to proceed.
The recalled product
- Product
- SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 72
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 (3)
- Lot Numbers: C63165
- C63306
- C63495
Distribution
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