Z-2315-2015Class II

Aequalis Humeral Nail Targeting Jig

Name: Z-2315-2015 Aequalis Humeral Nail Targeting Jig
Creator: Tornier, Inc
Published: 2015-06-25
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2015-06-25 / Terminated / root cause: manufacturing process

FDA source

Tornier, Inc began a recall of Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument on 2015-06-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2315-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-25
Posted: 2015-07-29
Terminated: 2017-08-31
Recalling firm: TORNIER Inc.
Product: Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 99
Distribution: US: AL, AK, AZ, CA, CO, CT, FL, IL, IN, ME, MD, MI, MO, NC, OH, PA, TX. OUS: CANADA AND FRANCE.
Product codes and lots: Lots: DB0114069, DB0114349, CA46096, CA216052, DB0111264001, DB0112016, DB0113102.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2315-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2315-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-05	2015-07-29

Product code HSB

K082754Class IIAequalis Humeral Nail SystemTornier / cleared 2009-01-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)