Z-0604-2018Class II

11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile

Name: Z-0604-2018 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
Creator: Synthes (USA) Products LLC
Published: 2017-07-21
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2017-07-21 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile on 2017-07-21. FDA classified it as Class II and gives the reason as "The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0604-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-21
Posted: 2018-02-13
Terminated: 2018-07-10
Recalling firm: Synthes (USA) Products LLC
Product: 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The company issued a recall letter on 7/21/2017 asking customers to quarantine affected product and arrange for it to be returned.
Quantity in commerce: 4 units
Distribution: TX, GA, PA, UT and Canada
Product codes and lots: Lot H302839, Expiration Date 31Jan2026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0604-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0604-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-13

Product code HSB

K011857Class IISynthes (USA) Trochanteric Fixation Nail (Tfn) SystemSynthes (Usa) / cleared 2001-09-12

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)