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
|