—#162248

Product

ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM STERILE ATN AR SCREW 70MM STERILE ATN AR SCREW 75MM STERILE ATN AR SCREW 80MM STERILE ATN AR SCREW 85MM STERILE ATN AR SCREW 90MM STERILE ATN AR SCREW 95MM STERILE ATN AR SCREW 100MM STERILE The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K010780, K013563, K042325, K111663
Affected lot / code info: 903305060 903305065 903305070 903305075 903305080 903305085 903305090 903305095 903305100

Why it was recalled

Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.

Root cause (FDA determination)

Device Design

Action the firm took

On December 22, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to customers with a complete list of products subject to recall and requesting that the customer review the notification and notify all affected personnel of the recall. If there is affected product at the facility it is requested that these units be quarantined and returned to a sales representative for return to the firm. Questions or concerns can be directed to 574-371-3071.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: USA (nationwide)

Timeline

Recall initiated: 2017-12-20
Posted by FDA: 2018-03-14
Terminated: 2020-04-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162248. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.