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

Lot, batch or date codes903211125 903211130 903211135

Quantity recalled3454

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-1229-2018
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 11X180 125DG STRL TROCH NAIL ST 11X180 130DG STRL TROCH NAIL ST 11X180 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)

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

903211125 903211130 903211135

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

10 other products · FDA event 79408

This product is part of a recall event; the main page for the event is ACE Trochanteric Nail System Ster Troc Nail 180X11X140 Ster recalled.

Reported	Class	Recall	Company	Reason	Where
4 Apr 2018	CLASS II	ACE Trochanteric Nail System Ster Troc Nail 180X11X140 Ster recalled	Zimmer Biomet	Packaging Defects	Nationwide
4 Apr 2018	CLASS II	ACE Trochanteric Nail System Ster Troc Lag Scr recalled by Zimmer Biomet	Zimmer Biomet	Packaging Defects	Nationwide
4 Apr 2018	CLASS II	ACE Trochanteric Nail System ACE Troch Nail 125 Deg recalled	Zimmer Biomet	Packaging Defects	Nationwide
4 Apr 2018	CLASS II	ACE Trochanteric Nail System Ster L H Troc Nail 320X9X125 recalled	Zimmer Biomet	Other	Nationwide
4 Apr 2018	CLASS II	ACE Trochanteric Nail System Ster Troc Nail 180X13X140 Ster recalled	Zimmer Biomet	Packaging Defects	Nationwide
4 Apr 2018	CLASS II	ACE Trochanteric Nail System Troch Nail ST 125DG Strl Troch recalled	Zimmer Biomet	Packaging Defects	Nationwide
4 Apr 2018	CLASS II	ACE Trochanteric Nail System Atn Lag Screw Sterile Atn Lag recalled	Zimmer Biomet	Packaging Defects	Nationwide
4 Apr 2018	CLASS II	ACE Trochanteric Nail System Ster Troc End Cap Ster Troc recalled	Zimmer Biomet	Packaging Defects	Nationwide
4 Apr 2018	CLASS II	ACE Trochanteric Nail System Ster Troc Nail 125 Deg Ster recalled	Zimmer Biomet	Packaging Defects	Nationwide
4 Apr 2018	CLASS II	ACE Trochanteric Nail System Atn AR Screw Sterile Atn AR recalled	Zimmer Biomet	Packaging Defects	Nationwide

More recalls from Zimmer Biomet

All 873

Reported	Class	Recall	Company	Reason	Where
30 Dec 2020Device	CLASS II	Spinal Rod Cutter recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
23 Dec 2020Device	CLASS II	Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal recalled	Zimmer Biomet	Device Malfunction	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D. recalled	Zimmer Biomet	Other	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Other	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Other	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide