Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
FDA Recall Z-2315-2015 · Posted 2015-07-29
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Recalling FirmTornier, Inc
Recall StatusTerminated
Product CodeHSB
Date Initiated2015-06-25
Date Terminated2017-08-31
Product Quantity99
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US: AL, AK, AZ, CA, CO, CT, FL, IL, IN, ME, MD, MI, MO, NC, OH, PA, TX. OUS: CANADA AND FRANCE.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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