Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed throug

FDA device recall Z-1799-2015 · posted 2015-06-15 · Terminated

Recall details

Recalling firm

Synthes, Inc.

Reason for recall

Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect hardness specification which could result in intraoperative breakage.

Action taken

DePuy Synthes sent an Urgent Notice Urgent notice dated May 28, 2015, to all affected customers to advise them of the defect and patient risks associated with its use. 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 by: Fax: (888) 943-5206 or Scan/email: Synthes2912@stericycle.com 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 by: Fax: (888) 943-5206 or Scan/email: Synthes2912@stericycle.com 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 3 of the notification. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.

Root cause

Component design/selection

Status

Terminated

Product code

FZX

Quantity affected

3747 US, 19 Foreign

Distribution

Worldwide Distribution-US (nationwide) and internationlly to Canada

Date initiated

2015-05-28

Date posted

2015-06-15

Date terminated

2016-08-22

Location

West Chester, PA