Tornier Recalls Aequalis Reversed II and Fracture Impactors
Tornier is voluntarily recalling Aequalis Reversed II and Fracture Impactors because the tip may separate during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a component separated during surgery, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Tornier, Inc. is voluntarily recalling all lots of Aequalis Reversed II and Aequalis Reversed Fracture Impactors. These instruments are used during shoulder arthroplasty to set the glenoid sphere, poly insert, spacer, and hemi adapter into place. The affected items are MWD21, MWD023, MWD024, and MWD025, which are contained within the Aequalis Reversed II Instrument set tray (no. YKAD83) and the Aequalis Reversed Fracture Instrument set tray (no. YKAD95).
The recall was initiated after Tornier identified an instance where an impactor tip disassociated during surgery. Following a review of the event, the company determined that a redesign of the instrument was warranted. The impactor is a two-piece instrument consisting of a tip and a handle, with the tip made of plastic and metal pressed together for assembly.
A total of 2,298 units were distributed worldwide, including 1,045 in the United States and 1,253 outside the US. Distribution included the United States (including Puerto Rico and specific states), Canada, Mexico, and various countries in Europe, Asia, and South America. Healthcare providers should stop using these instruments and contact Tornier for further instructions.
The recalled product
- Product
- AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025.
- Manufacturer
- Tornier, Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots
Distribution
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