Tornier Recalls Salto Talaris Tibial Guide Due to Assembly Defect
Tornier is voluntarily recalling five units of the Salto Talaris Tibial Guide because they cannot be assembled to the Talar Pin Setting guide.
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 a voluntary precautionary action for a functional defect that prevents the instrument from being used as intended, with no reported injuries or illnesses.
Plain-English summary
Tornier, Inc. has initiated a voluntary recall of the Salto Talaris Tibial Guide (Part # MJU333, Tray/Kit Code YKAL11, Lot #14F005). The recall involves five non-sterile orthopedic manual surgical instruments.
The recall was initiated due to a complaint received during physician training that the guide cannot be assembled to the Salto Talaris Talar Pin Setting guide. This defect makes it impossible to place the Talar pin in the guide.
The affected units were distributed to California, Maine, North Carolina, Pennsylvania, and Texas. Users should stop using the recalled instruments and contact Tornier for instructions on return or replacement.
The recalled product
- Product
- Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument
- Manufacturer
- Tornier, Inc
- Hazard
- Affected units
- 5
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 #14F005
Distribution
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