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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy Synthes TI Vectra Plates

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  Class 2 Device Recall DePuy Synthes TI Vectra Plates see related information
Date Initiated by Firm September 02, 2014
Date Posted September 22, 2014
Recall Status1 Terminated 3 on September 02, 2015
Recall Number Z-2674-2014
Recall Event ID 69178
510(K)Number K071667  K050451  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
Product DePuy Synthes TI Vectra Plates:

TI Vectra-One" Plate 2 Level / 34 mm
part 04.613.184
3337672

TI Vectra" Plate 3 Level / 57 mm
part 04.613.257
lot 3693878

TI Vectra" Plate 4 Level / 64 mm
part 04.613.364
lot 8143905
Code Information TI Vectra-One" Plate 2 Level / 34 mm  part 04.613.184  3337672  TI Vectra" Plate 3 Level / 57 mm  part 04.613.257  lot 3693878  TI Vectra" Plate 4 Level / 64 mm  part 04.613.364  lot 8143905   
Recalling Firm/
Manufacturer		 Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 DePuy Synthes is initiating a voluntary medical device recall of certain lots of the TI Vectra Plates, which is a part of the DePuy Synthes Vectra Anterior Cervical Plate Family of Systems. The Vectra Systems are intended for anterior screw fixation to the cervical spine (C2-C7). It was discovered in certain lots, that the clips are potentially missing from the TI Vectra Plates resulting in the i
FDA Determined
Cause 2		 Employee error
Action DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated September 2, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please take the following actions: If you DO 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: (610) 430-7083 or Scan/email: Fieldaction@synthes.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 information. Return the documents to DePuy Synthes by: Fax: (610) 430-7083 or Scan/email: Fieldaction@sythes.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. If you have any questions, please call 610-719-5450, or contact your DePuy Synthes sales consultant.
Quantity in Commerce 16
Distribution US Distribution including the states of IL, SC, VA, TX, MA, NC, LA, CA, AL, CO, NE, OR and KS., and Internationally to Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWQ and Original Applicant = SYNTHES SPINE
510(K)s with Product Code = KWQ and Original Applicant = SYNTHES SPINE CO.LP
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