CLASS II Device recall · Reported 2 Sep 2015 · FDA Enforcement Report

Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit recalled by Tornier

Tornier is recalling Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile, distributed in California, Maine, North Carolina, Pennsylvania, Texas. The recall was initiated on 6 Aug 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #14F005

Quantity recalled5

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2465-2015
FDA event ID: 71913
Recalling firm: Tornier, Bloomington, MN
Classification: Class II
Status: Terminated
Recall initiated: 6 Aug 2015
FDA classified: 26 Aug 2015
Reported: 2 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

6 Aug 2015	Recall initiated by company
26 Aug 2015	Classified by FDA	+20 days
2 Sep 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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

Where it was distributed

Distributed to CA, ME, NC, PA, and TX.

California Maine North Carolina Pennsylvania Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot #14F005

Where was it sold?

Distributed to CA, ME, NC, PA, and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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