Recall Z-2465-2015— Tornier, Inc

Name: FDA recall Z-2465-2015
Creator: U.S. Food and Drug Administration
Published: 2015-08-06

Class II · Terminated

Class II FDA medical device recall by Tornier, Inc, initiated 2015-08-06, terminated 2016-04-08. It names one FDA 510(k) clearance: K130533. 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..

Recalling firm: Tornier, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-08-06
Terminated: 2016-04-08
Firm location: Bloomington, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K130533 — SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHSTornier S.A.S.·cleared 2013-05-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.