Z-0126-2016Class II

Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element...

Name: Z-0126-2016 Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element...
Creator: Synthes (USA) Products LLC
Published: 2015-09-21
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2015-09-21 / Terminated / root cause: design

FDA source

Synthes (USA) Products LLC began a recall of Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent... on 2015-09-21. FDA classified it as Class II and gives the reason as "Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument". 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-0126-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-21
Posted: 2015-10-15
Terminated: 2016-08-26
Recalling firm: Synthes (USA) Products LLC
Product: Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument.
Root cause tag: design
FDA root cause: Device Design
Action: DePuy Synthes sent an urgent notice of medical device recall letter dated September 21, 2015, to all affected customers to notify them about the issue, the potential risks, and to provide instructions for return of the completed response form and affected devices. Customers with questions were instructed to call 610-719-5450.
Quantity in commerce: 793
Distribution: US Nationwide Distribution
Product codes and lots: Part Number 03.037.025 Lot Numbers 8911887; 8911975; 9166356; 9285766; 9286671; 9319408; 9375245; 9375251; 9388359; 9388360; 9393071; 9393074; 9393075; 9393076; 9409795; 9409796; 9422892; 9422895; 9498455; 9310899; 9310900; 9319407

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0126-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0126-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-21	2015-10-15

Product code HSB

K131548Class IISynthes Trochanteric Fixation Nail - Advanced SystemSynthes (USA) Products, LLC / cleared 2014-02-28

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)