Recall Z-2315-2015 ยท HSB Rod, Fixation, Intramedullary And Accessories
Tornier, Inc
Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
| Date | Jul 29, 2015 (initiated Jun 25, 2015) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082754 | AEQUALIS HUMERAL NAIL SYSTEM Tornier, Jan 27, 2009 |