Recall Z-1757-2018 ยท HTW Bit, Drill
Tornier, Inc
AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications
| Date | Mar 26, 2018 |
| Status | Terminated |
| Reason | Drill bit tips without new BargerGard tip protector may puncture through sterile packaging. |
| Root cause | Package design/selection |
| Action | The firm contacted its distributors by email on 26-March-2018, and a written letter sent 27-March-2018 via FedEx. The Medical Facility was contacted with a written letter sent 28-March-2018 via FedEx.. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete and return the attached Acknowledgement to Wright Medical via email to FieldAction@wright.com. For questions call 952-683-7482. |
| Quantity | 3327 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082754 | AEQUALIS HUMERAL NAIL SYSTEM Tornier, Jan 27, 2009 |