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Recall Observatory FDA recall evidence

Device product

Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.

Z-2315-2015

June 25, 2015

Class II

Product summary

Firm
Tornier, Inc
Event
Event 71605
Status
Terminated
Classification
Class II
Quantity
99
Official record key
device-enforcement:Z-2315-2015

Official wording

Reason: Recall for the Aequalis IM Nail instrumentation set (Tray Number 9020000) due to several reports that the mast of the targeting jig (Part Number 9020060) is separating from the jig boom. Separation will impact alignment and can affect the ability to fixate Aequalis IM Nail screws.

Code information: Lots: DB0114069, DB0114349, CA46096, CA216052, DB0111264001, DB0112016, DB0113102.

Distribution pattern: US: AL, AK, AZ, CA, CO, CT, FL, IL, IN, ME, MD, MI, MO, NC, OH, PA, TX. OUS: CANADA AND FRANCE.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Recall for the Aequalis IM Nail instrumentation set (Tray Number 9020000) due to several reports that the mast of the targeting jig (Part Number 9020060) is separating from the jig boom. Separation will impact alignment and can affect the ability to fixate Aequalis IM Nail screws.