Smith & Nephew Recalls Intertan 10S Orthopedic Nails Due to Assembly Error
Smith & Nephew is recalling 17 units of Intertan 10S orthopedic nails because the set screw was inserted upside down during manufacturing.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a manufacturing assembly error (screw inserted upside down) but does not report any illnesses, injuries, or deaths. Per the rubric, a Class II recall without reported hospitalizations or significant injuries falls under Moderate severity.
Plain-English summary
Smith & Nephew, Inc. is recalling 17 units of the TRIGEN INTERTAN 10S orthopedic nail (Reference 71675384, 10 mm x 18 cm, 130 degrees). The recall involves a single lot, identified as Lot number 16LM07111.
The recall was initiated because the set screw was inserted upside down during the manufacturing process. This defect affects the preassembled set screw in the nail.
The affected units were distributed in the United States to Tennessee, Illinois, Connecticut, Missouri, and California, as well as internationally to Italy and Germany. Healthcare providers and facilities that have received these specific units should stop using them and contact Smith & Nephew for instructions on return or replacement.
The recalled product
- Product
- smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 17
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 (1)
- Lot number 16LM07111
Distribution
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