Aequalis Humeral Nail Targeting Jig, Product Code:… recallZ-2315-2015 · Tornier, Inc · initiated Jun 25, 2015
Class II Terminated All recalls posted in July 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Tornier, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Consignees were sent on 6/25/2015 a Tornier "Urgent Medical Device Recall" letter dated June 24, 2015. The letter described the problem and the product affected by the recall. The letter provided information on jig inspection and referred consignee to the attached "Perfect Circles' surgical technique that should be used when separation is observed. Requested consignees to complete and return the questionnaire to [email protected]. For questions they can contact Customer Service Department at 1(888)494-7950.
Recall details
- Recall number
- Z-2315-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 25, 2015
- Posted by the FDA
- Jul 29, 2015
- Recalling firm
- Tornier, Inc
- Quantity
- 99
- Product code
- HSB
- FDA submissions
- K082754
- Distribution
- US: AL, AK, AZ, CA, CO, CT, FL, IL, IN, ME, MD, MI, MO, NC, OH, PA, TX. OUS: CANADA AND FRANCE.
Product description
Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
Code information (models, lots, serial numbers)
Lots: DB0114069, DB0114349, CA46096, CA216052, DB0111264001, DB0112016, DB0113102.
Other devices under the same FDA submission
2 devices cleared under K082754 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Tornier Humeral Nail 0020500Tornier, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- Tornier Humeral Nail 0020600Tornier, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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