Z-1514-2018Class II

Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca...

Name: Z-1514-2018 Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca...
Creator: Synthes, Inc.
Published: 2018-03-19
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2018-03-19 / Terminated / root cause: design

FDA source

Synthes, Inc. began a recall of Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants on 2018-03-19. FDA classified it as Class II and gives the reason as "There is a potential for the connection screw of the stem extractor to break". 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-1514-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-19
Posted: 2018-04-25
Terminated: 2019-04-11
Recalling firm: Synthes GmbH
Product: Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
Product code: HWB Extractor
Reason for recall: There is a potential for the connection screw of the stem extractor to break.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, DePuy Synthes, sent an "URGENT FIELD SAFETY NOTICE" dated 3/19/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to the following: Review the instructions listed in this notification. Forward this notice to anyone in your facility that needs to be informed. If any of the affected product has been forwarded to another facility, contact that facility. Keep a copy of this notice. Return the Verification Section (page 3 of this letter) to Synthes by: o Fax: 1-888-731-7954 or o Scan/email: [email protected] . Follow the Instructions if connecting screw for the stem extractor breaks If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.
Quantity in commerce: 31
Distribution: Worldwide Distribution: US (nationwide) and to countries of: Canada and Switzerland.
Product codes and lots: 09-6793, 10-2637, 10-5070, 12-2707, 14-1085, 15-8949

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1514-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1514-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-25

Product code HWB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)