Recall Z-2465-2015 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Tornier, Inc
Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument
| Date | Aug 26, 2015 (initiated Aug 6, 2015) |
| Status | Terminated |
| 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. |
| 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 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 | 5 |
| Distribution | Distributed to CA, ME, NC, PA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130533 | SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS Tornier S.A.S., May 17, 2013 |