Z-0615-2014Class II

Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated...

Name: Z-0615-2014 Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated...
Creator: Synthes USA HQ, Inc.
Published: 2013-04-15
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-04-15 / Terminated / root cause: manufacturing process

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement... on 2013-04-15. FDA classified it as Class II and gives the reason as "Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. 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-0615-2014
Classification: Class II
Status: Terminated
Initiated: 2013-04-15
Posted: 2013-12-31
Terminated: 2016-09-14
Recalling firm: Synthes GmbH
Product: Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 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: Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. The "on" and "lock" labels were interchanged.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Synthes sent an Urgent Notice: Medical Device Recall letter dated April 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. 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 at 1-800-479-6329 to obtain a Return Authorization (RA) Number. Complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product has been located. Return the Verification Form with the product to: Credit/Returns, Synthes 1101 Synthes Avenue Monument, CO 80132 If customers do not have the affected product they should still complete the Verifcation Section at the end of the letter by checking the appropriate box and faxing the document to 610-251-9005 or email to: [email protected] 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: 290
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada. .
Product codes and lots: Part Number 05.001.012, lot number AV18166

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0615-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0615-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-31

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