Z-1711-2015Class II

3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC...

Name: Z-1711-2015 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC...
Creator: Synthes, Inc.
Published: 2015-05-13
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2015-05-13 / Terminated / root cause: design

FDA source

Synthes, Inc. began a recall of 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication for Synthes... on 2015-05-13. FDA classified it as Class II and gives the reason as "affected parts and lots of the Cannulated Drill Bits have the potential to break during use". 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-1711-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-13
Posted: 2015-06-04
Terminated: 2016-08-18
Recalling firm: Synthes GmbH
Product: 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.
Product code: HTW Bit, Drill
Reason for recall: affected parts and lots of the Cannulated Drill Bits have the potential to break during use
Root cause tag: design
FDA root cause: Component design/selection
Action: DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated May 13, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed if they have any of the identified devices, please take the following steps: " Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. " Complete the Verification Section (page 3 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 3 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: (888) 943-4893 or " Scan/email: [email protected] If you DO NOT have the identified product, please take the following steps: " Complete the attached Verification Section (page 3 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: (888) 943-4893 or " Scan/email: [email protected] " Note: If the Verification Section is answered on behalf of more th An urgent medical device recall notice, dated May 13, 2015, was sent to consignees and sales consultants to in form them of the issue and associated risks. All in receipt of the device were asked to discontinue use and return affected devices along with the response form. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales
Quantity in commerce: 1495 US (37 OUS)
Distribution: Worldwide Distribution - US (nationwide) and Canada.
Product codes and lots: Part Number 310.65 310.67 310.221 lot numbers PE00966 PE01000 PE01039 PE01058 PE00959 PE00968 PE00974 PE00998 PE01006 PE01011 PE01048 PE00971 PE01059 PE01040

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1711-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1711-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-10	2015-06-04

Product code HTW

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)