Z-2465-2015Class II

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

Name: Z-2465-2015 Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical...
Creator: Tornier, Inc
Published: 2015-08-06
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2015-08-06 / Terminated / root cause: manufacturing process

FDA source

Tornier, Inc began a recall of Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument on 2015-08-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2465-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-06
Posted: 2015-08-26
Terminated: 2016-04-08
Recalling firm: TORNIER Inc.
Product: Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument
Product code: HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Distributors were sent on 8/6/2015 a Tornier "Urgent - Medical Device Recall" letter, dated August 5, 2015. The letter described the problem and the product involved in the recall. Consignees were advised to review their inventory and the inventory of all reps within their area for the recalled device. The letter requested that consignees complete and return the questionnaire to [email protected]. A Tornier representative will organize the collection and replacement of the devices. For questions they can contact Customer Service Department at 1 (888) 494-7950.
Quantity in commerce: 5
Distribution: Distributed to CA, ME, NC, PA, and TX.
Product codes and lots: Lot #14F005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2465-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2465-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-26

Product code HSN

K130533Class IISalto Talaris Total Ankle Prosthesis, RhsTornier S.A.S. / cleared 2013-05-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)