Smith & Nephew Recalls Legion Fem Cone Impactor Heads Due to Adhesive Error
Smith & Nephew is recalling 36 units of Legion Fem Cone Impactor Heads because incorrect Loctite adhesive was used during assembly.
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 does not report any illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Smith & Nephew, Inc. is recalling 36 units of LEGION(R) FEM CONE IMPACTOR HEADS. The affected products include reference numbers 71441976 (18mm), 71441977 (20mm), and 71441978 (22mm). The specific lot numbers involved are 16HGA0031, 16HGA0034, and 16HGA0035.
The recall was initiated because the incorrect Loctite adhesive was used to assemble the impactor heads. This manufacturing error could potentially affect the integrity of the device.
The affected units were distributed in the United States to Tennessee. Healthcare providers and facilities that may have received these specific lots should stop using the devices and contact Smith & Nephew for further instructions.
The recalled product
- Product
- LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 36
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 numbers: a) 16HGA0031 b) 16HGA0034 c) 16HGA0035
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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