FDA Medical Device Recalls (openFDA)
Tornier, Inc: Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
- Recall number
- Z-2315-2015
- Recalling firm
- Tornier, Inc
- Product
- Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
- Status
- Terminated
- Initiated
- 2015-06-25
- Posted
- 2015-07-29
- Terminated
- 2017-08-31
- 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.
- 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 FieldAction@tornier.com. For questions they can contact Customer Service Department at 1(888)494-7950.
- Quantity
- 99
- Distribution
- US: AL, AK, AZ, CA, CO, CT, FL, IL, IN, ME, MD, MI, MO, NC, OH, PA, TX. OUS: CANADA AND FRANCE.
- Lot, serial or model codes
- Lots: DB0114069, DB0114349, CA46096, CA216052, DB0111264001, DB0112016, DB0113102.
- 510(k) numbers
- ["K082754"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3000718467
- Firm city
- Bloomington
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28