Tornier Recalls
26 recalls on record in the United States
Tornier, Inc recalls TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE,
A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.
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Tornier S.A.S. recalls Blueprint Software, BPUE001. Intended for use by surgeons a
A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
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Tornier, Inc recalls stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, S
A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)
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Tornier S.A.S. recalls stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Numb
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
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Tornier S.A.S. recalls stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog N
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
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Tornier S.A.S. recalls stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Numb
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
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Tornier S.A.S. recalls stryker Blueprint Mixed Reality Instrument Kit, Catalog Numb
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
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Tornier S.A.S. recalls stryker Blueprint Mixed Reality Box Base, Catalog Number MRU
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
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Tornier S.A.S. recalls stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPS
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
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Tornier S.A.S. recalls stryker Blueprint Mixed Reality Instrument Check Block, Cata
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
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Tornier S.A.S. recalls stryker HoloBlueprint Application, Catalog Number MRUE001; T
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
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Tornier S.A.S. recalls stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Num
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
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Tornier S.A.S. recalls Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, RE
The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to conventional.
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Tornier, Inc recalls Stryker Tornier Perform Humeral System, Reversed Insert, 45
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 spacer.
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Tornier, Inc recalls stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomi
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
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Tornier S.A.S. recalls Stryker Blueprint Software, Catalog #BPUE001.
The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.
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Tornier, Inc recalls Stryker Tornier Perform Reversed Glenoid Press-Fit Short Pos
The incorrect device is contained in the labeled package.
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Tornier, Inc recalls stryker Tornier Perform Reversed Augmented Glenoid Lateraliz
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 being able to thread into the baseplate.
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Tornier, Inc recalls AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number
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 Assembly Screw 0mm Short (ARS655118) & vice versa.
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Tornier, Inc recalls AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655
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 Assembly Screw 0mm Short (ARS655118) & vice versa.
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Tornier, Inc recalls Ratcheting Screwdriver Handle, provided in the Aequalis Perf
The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.
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Tornier S.A.S. recalls The Aequalis Pyrocarbon Humeral Heads. Shoulder implant com
Potential patient exposure to the graphite substrate.
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Tornier, Inc recalls Aequalis Ascend Flex Shoulder System Reversed Platform (Reve
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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Tornier, Inc recalls Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A
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 cause the product to rub against the PETG blister shipping container causing the transfer of PETG material from the blister container to the stem.
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Tornier, Inc recalls AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usa
Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
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Tornier, Inc recalls Fornier Phantom Fiber(TM) Sutures: Item Number Description
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 cause the suture to lose strength more quickly than expected.
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