Tornier, Inc — Federal Records

FDA Device Recall: Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for 2024-10-09

Class II — Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or space...

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FDA Device Recall: stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM00 2024-09-25

Class II — One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).

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FDA Device Recall: Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ00 2024-01-31

Class II — The incorrect device is contained in the labeled package.

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FDA Device Recall: stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, 2023-10-25

Class II — One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from...

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FDA Device Recall: AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118 2023-07-05

Class II — A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Ass...

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FDA Device Recall: AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101 2023-07-05

Class II — A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Ass...

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FDA Device Recall: Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit 2022-06-08

Class II — The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.

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FDA Device Recall: Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) 2021-07-21

Class II — Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.

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FDA Device Recall: Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF6 2019-11-20

Class II — During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraints. Movement within the packaging may c...

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FDA Device Recall: AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Hu 2018-05-16

Class II — Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.

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FDA Device Recall: Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PH 2018-04-25

Class II — Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly than expected if improperly stored. This may impact the shelf-life of the product which could...

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FDA Device Recall: Aequalis Fx2 implant parts and instrument trays. Insert component : Part Num 2016-12-14

Class II — Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to reports of dislocations of the poly insert and the stem.

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FDA Device Recall: Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. 2015-09-02

Class II — 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 assemb...

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FDA Device Recall: AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are 2013-09-25

Class II — Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Fracture impa...

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