RecallRadar

FDA Device recall Z-2465-2015

Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile

On 2015-09-02 the FDA classified a Class II recall of Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile by Tornier, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2465-2015
ClassificationClass II
Statusterminated
Initiated2015-08-06
Published2015-09-02
Last updated2026-09-13 11:53 UTC
CompanyTornier
DistributionCA, ME, NC, PA, TX

Product

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

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.

Identifiers

code_infoLot #14F005

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2465-2015%22

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