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.
This recall has been terminated (originally issued June 4, 2015).
- Company
- Synthes, Inc.
- Recall Initiated
- May 13, 2015
- Posted
- June 4, 2015
- Terminated
- August 18, 2016
- Recall Number
- Z-1711-2015
- Quantity
- 1495 US (37 OUS)
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
affected parts and lots of the Cannulated Drill Bits have the potential to break during use
Distribution
Worldwide Distribution - US (nationwide) and Canada.
Lot / Code Info
Part Number 310.65 310.67 310.221 lot numbers PE00966 PE01000 PE01039 PE01058 PE00959 PE00968 PE00974 PE00998 PE01006 PE01011 PE01048 PE00971 PE01059 PE01040
Root Cause
Component design/selection
Action Taken
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: Synthes6230@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 to DePuy Synthes by: " Fax: (888) 943-4893 or " Scan/email: Synthes6230@stericycle.com " 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