Z-1313-2015Class II

Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin...

Name: Z-1313-2015 Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin...
Creator: Synthes, Inc.
Published: 2014-12-19
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2014-12-19 / Terminated / root cause: manufacturing process

FDA source

Synthes, Inc. began a recall of Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal... on 2014-12-19. FDA classified it as Class II and gives the reason as "In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive was not labeled correctly, and the on and lock labels were interchanged". 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-1313-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Posted: 2015-03-23
Terminated: 2016-05-19
Recalling firm: Synthes GmbH
Product: Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.
Product code: HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Reason for recall: In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive was not labeled correctly, and the on and lock labels were interchanged.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Synthes sent an Urgent Medical Device Recall Notice, dated December 19, 2014, to all affected customers to provide updated information on additional lots identified. Customers were instructed to examine their inventory for the affected product, remove from inventory, and return them to Synthes immediately for replacement. Customers were instructed to call Synthes to obtain a Return Authorization (RA) Number, complete the Verification Section at the end of the letter, and return the Verification Form with the product to: Credit/Returns, Synthes 1101 Synthes Avenue Monument, CO 80132. Customers with questions were instructed to call 610-719-5450 or email [email protected]. For questions regarding this recall call 610-719-5000.
Quantity in commerce: 249
Distribution: Nationwide Distribution
Product codes and lots: Part Number 05.001.012 Lot Numbers AV18166 AV19044 AV20666

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1313-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1313-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-23

Product code HWE

K043310Class ISynthes (USA) Electric Pen Drive SystemSynthes (Usa) / cleared 2005-01-05

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)