Z-1225-2018Class II

ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135...

Name: Z-1225-2018 ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135...
Creator: Zimmer Biomet, Inc.
Published: 2017-12-20
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-12-20 / Terminated / root cause: design

FDA source

Zimmer Biomet, Inc. began a recall of ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 125 DEG. X 13MM ACE... on 2017-12-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1225-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-20
Posted: 2018-03-14
Terminated: 2020-04-22
Recalling firm: Zimmer GmbH
Product: ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 125 DEG. X 13MM ACE TROCH NAIL 130 DEG. X 13MM ACE TROCH NAIL 135 DEG. X 13MM 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.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 3454
Distribution: USA (nationwide)
Product codes and lots: 903011225 903011230 903011235 903013225 903013230 903013235

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1225-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1225-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1226-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1227-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1228-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1229-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1230-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1231-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1232-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1233-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1234-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1235-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27

Product code HSB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)