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Recall Observatory FDA recall evidence

Device product

Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument

Z-2465-2015

August 06, 2015

Class II

Product summary

Firm
Tornier, Inc
Event
Event 71913
Status
Terminated
Classification
Class II
Quantity
5
Official record key
device-enforcement:Z-2465-2015

Official wording

Reason: Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) due to a complaint that occurred during physician training, that the guide cannot be assembled to the Salto Talaris Talar Pin Setting guide. This issue will cause the impossibility the time of putting the Talar pin in the guide.

Code information: Lot #14F005

Distribution pattern: Distributed to CA, ME, NC, PA, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) due to a complaint that occurred during physician training, that the guide cannot be assembled to the Salto Talaris Talar Pin Setting guide. This issue will cause the impossibility the time of putting the Talar pin in the guide.