Z-0931-2015Class II

Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in...

Name: Z-0931-2015 Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in...
Creator: Synthes (USA) Products LLC
Published: 2014-11-06
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2014-11-06 / Terminated / root cause: design

FDA source

Synthes (USA) Products LLC began a recall of Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food... on 2014-11-06. FDA classified it as Class II and gives the reason as "The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. Unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue...". 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-0931-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-06
Posted: 2015-01-07
Terminated: 2015-08-17
Recalling firm: Synthes (USA) Products LLC
Product: Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and hard tissue.
Product code: HTC Pliers, Surgical
Reason for recall: The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. Unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue, peripheral nerve, and /or vascular damage. Injuries may need surgical or medical intervention. Surgical delay and postoperative local infection are also potential risks.
Root cause tag: design
FDA root cause: Device Design
Action: DePuy Synthes sent an Urgent Notice: Medical Device Removal letter dated November 6, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify their consignees using the hospital personnel letter, dated November 6, 2014, as their template for their consignee notification letter, review their inventory and remove the affected lots from stock. Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. Complete the Verification Section (page 4 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. Return the Verification Section (page 4 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Send a copy of the completed Verification Section to DePuy Synthes by: Fax: (610) 430-7083 or Scan/email: [email protected] If you DO NOT have the identified product, please take the following steps: Complete the attached Verification Section (page 4 of this letter) by checking the appropriate box indicating that no affected product has been located. Please include your name, title, address, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device removal information. Return the documents to DePuy Synthes by: Fax: (610) 430-7083 or Scan/email: [email protected] Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 4 of the notification. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.
Quantity in commerce: 12
Distribution: US Nationwide Distribution to Florida only
Product codes and lots: All lots of part number 05.001.175, lot numbers: 28, 40, 41, 42, 53, 105, 107, 111, 112, 113, 115.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0931-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0931-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-07

Product code HTC

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)