ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM STERILE ATN AR SCREW 70MM STERILE ATN AR SCREW
FDA device recall Z-1233-2018 · posted 2018-03-14 · Terminated
Recall details
- Recalling firm
- Zimmer Biomet, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 3454
- Distribution
- USA (nationwide)
- Date initiated
- 2017-12-20
- Date posted
- 2018-03-14
- Date terminated
- 2020-04-22
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRAUMA INTERNAL FIXATION SYSTEMS (K111663) | DePuy Orthopaedics, Inc. | 2012-03-12 |
| TROCHANTERIC NAIL SYSTEM (K042325) | DePuy Orthopaedics, Inc. | 2004-09-08 |
| LONG TROCHANTERIC NAIL SYSTEM (K013563) | DePuy Orthopaedics, Inc. | 2001-12-27 |
| TROCHANTERIC NAIL (K010780) | DePuy Orthopaedics, Inc. | 2001-06-12 |