Zimmer Biomet Recalls ACE Trochanteric Nail System Screws
Zimmer Biomet is recalling ACE Trochanteric Nail System screws because a device performance review failed clinical analysis for survivorship.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a failure in clinical analysis for survivorship, which implies a risk of device failure, but the source text does not report any specific injuries, illnesses, or deaths. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Zimmer Biomet, Inc. is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system. The specific items involved are ATN AR Screws in various lengths, ranging from 60mm to 100mm, which are sterile. The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur, including pertrochanteric, intertrochanteric, and high subtrochanteric fractures.
The recall was initiated after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system. The source text does not specify the number of units affected, the distribution dates, or any reported injuries or illnesses.
Healthcare providers and patients who have received these devices should contact Zimmer Biomet for further instructions. The source text does not provide specific contact information or detailed remediation steps beyond the initiation of the recall.
The recalled product
- 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 Th
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 3,454
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
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