Z-2315-2015 Class II Terminated
FDA device recall Z-2315-2015 was initiated by Tornier, Inc on Jun 25, 2015 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Aug 31, 2017). Affected quantity: 99.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 5, 2015
- Initiation Date
- Jun 25, 2015
- Termination Date
- Aug 31, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 99
Product Description
Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
Reason for Recall
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.
Distribution Pattern
US: AL, AK, AZ, CA, CO, CT, FL, IL, IN, ME, MD, MI, MO, NC, OH, PA, TX. OUS: CANADA AND FRANCE.
Code Information
Lots: DB0114069, DB0114349, CA46096, CA216052, DB0111264001, DB0112016, DB0113102.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2315-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026