The Recall Desk
HighFDA (Devices)·Z-0730-2019·Announced 2019-01-23

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.

What this means for you

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
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

Distributed in 2 states: