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DePuy Synthes TI Vectra Plates recallZ-2674-2014 · Synthes, Inc. · initiated Sep 2, 2014

Class II Terminated All recalls posted in September 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Employee error

What the company is doing

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: [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 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 3 of the notification. If you have any questions, please call 610-719-5450, or contact your DePuy Synthes sales consultant.

Recall details

Recall number
Z-2674-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 2, 2014
Posted by the FDA
Sep 22, 2014
Recalling firm
Synthes, Inc.
Quantity
16
Product code
KWQ
FDA submissions
K050451, K071667
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.

Product description

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 (models, lots, serial numbers)

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

Other devices under the same FDA submission

11 devices cleared under K050451, K071667 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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