CLASS II Device recall · Reported 4 Apr 2018 · FDA Enforcement Report
ACE Trochanteric Nail System Troch Nail ST 125DG Strl Troch recalled
Zimmer Biomet is recalling ACE Trochanteric Nail System Troch Nail ST 125DG Strl Troch Nail ST 130DG Strl Troch Nail, distributed nationwide in the US. The recall was initiated on 20 Dec 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1231-2018
- FDA event ID
- 79408
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Dec 2017
- FDA classified
- 27 Mar 2018
- Reported
- 4 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 20 Dec 2017 | Recall initiated by company | |
| 27 Mar 2018 | Classified by FDA | +97 days |
| 4 Apr 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X180 130DG STRL TROCH NAIL ST 13X180 135DG STRL 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.
Where it was distributed
USA (nationwide)
Questions about this recall
Is ACE Trochanteric Nail System Troch Nail ST 125DG Strl Troch Nail ST 130DG Strl Troch Nail recalled?
Yes. Zimmer Biomet recalled ACE Trochanteric Nail System Troch Nail ST 125DG Strl Troch Nail ST 130DG Strl Troch Nail on 20 Dec 2017. The recall is Class II and its status is Terminated. Recall number Z-1231-2018.
Why was it 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.
Which lots are affected?
903213125 903213130 903213135
Where was it sold?
USA (nationwide)
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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