Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
FDA device recall Z-2315-2015 · posted 2015-07-29 · Terminated
Recall details
- Recalling firm
- Tornier, Inc
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 99
- Distribution
- US: AL, AK, AZ, CA, CO, CT, FL, IL, IN, ME, MD, MI, MO, NC, OH, PA, TX. OUS: CANADA AND FRANCE.
- Date initiated
- 2015-06-25
- Date posted
- 2015-07-29
- Date terminated
- 2017-08-31
- Location
- Bloomington, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AEQUALIS HUMERAL NAIL SYSTEM (K082754) | Tornier | 2009-01-27 |