Recall Z-2315-2015— Tornier, Inc
Class II · Terminated
Class II FDA medical device recall by Tornier, Inc, initiated 2015-06-25, terminated 2017-08-31. It names one FDA 510(k) clearance: K082754. Product: Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.. 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..
- Recalling firm
- Tornier, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-25
- Terminated
- 2017-08-31
- Firm location
- Bloomington, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.