Smith & Nephew Recalls Legion Tib Cone Impactor Heads Due to Adhesive Error
Smith & Nephew is recalling 46 units of Legion Tib Cone Impactor Heads because incorrect Loctite adhesive was used during assembly.
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 FDA classified this as a Class II recall, and the source text does not report any illnesses or injuries, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smith & Nephew, Inc. is recalling 46 units of LEGION(R) TIB CONE IMPACTOR HEADS. The affected products include five specific reference numbers (71441972, 71441971, 71441973, 71441974, and 71441975) corresponding to internal diameters of 24mm, 22mm, 26mm, 28mm, and 30mm. The recall is associated with specific lot numbers: 16HGA0040, 16JGA0003, 16JGA0005, 16JGA0006, and 16JGA0007.
The recall was initiated because incorrect Loctite adhesive was used to assemble the impactor heads. This manufacturing error could potentially affect the integrity of the device. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected units were distributed in the United States to Tennessee. Healthcare providers and facilities that have received these specific lots of impactor heads should stop using them and contact Smith & Nephew for further instructions on return or replacement.
The recalled product
- Product
- LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 46
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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