Tornier Aequalis Humeral Nail Targeting Jig Recalled for Mast Separation
Tornier, Inc. is recalling 99 Aequalis Humeral Nail Targeting Jigs because the mast can separate from the boom, potentially affecting surgical alignment and screw fixation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a risk of harm (improper surgical fixation) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Tornier, Inc. is recalling 99 units of the Aequalis Humeral Nail Targeting Jig (Product Code 9020060), an orthopedic manual surgical instrument. The recall is due to reports that the mast of the targeting jig is separating from the jig boom.
This separation can impact alignment and affect the ability to fixate Aequalis IM Nail screws. The affected lots are DB0114069, DB0114349, CA46096, CA216052, DB0111264001, DB0112016, and DB0113102.
The products were distributed in the United States (AL, AK, AZ, CA, CO, CT, FL, IL, IN, ME, MD, MI, MO, NC, OH, PA, TX) and internationally in Canada and France. Healthcare providers should stop using the affected instruments and contact Tornier, Inc. for instructions on return or replacement.
The recalled product
- Product
- Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
- Manufacturer
- Tornier, Inc
- Affected units
- 99
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 (7)
- Lots: DB0114069
- DB0114349
- CA46096
- CA216052
- DB0111264001
- DB0112016
- DB0113102.
Distribution
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