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Terminated

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

FDA Recall Z-2465-2015 · Posted 2015-08-26

Recalling FirmTornier, Inc
Recall StatusTerminated
Product CodeHSN
Date Initiated2015-08-06
Date Terminated2016-04-08
Product Quantity5

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed to CA, ME, NC, PA, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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