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U.S. Department of Health and Human Services

Class 2 Device Recall Salto Talaris Tibial Guide

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  Class 2 Device Recall Salto Talaris Tibial Guide see related information
Date Initiated by Firm August 06, 2015
Date Posted August 26, 2015
Recall Status1 Terminated 3 on April 08, 2016
Recall Number Z-2465-2015
Recall Event ID 71913
510(K)Number K130533  
Product Classification Prosthesis, ankle, semi-constrained, cemented, metal/polymer - Product Code HSN
Product Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile.

Orthopedic Manual Surgical Instrument
Code Information Lot #14F005
Recalling Firm/
Manufacturer		 Tornier, Inc
10801 Nesbitt Ave S
Bloomington MN 55437-3109
For Additional Information Contact Customer Service
888-494-7950
Manufacturer 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.
FDA Determined
Cause 2		 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 FieldAction@tornier.com. 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSN and Original Applicant = Tornier SAS
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