URGENT FIELD SAFETY NOTICE MEDICAL DEVICE RECALL by StuartReardon

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									                  URGENT: FIELD SAFETY NOTICE
                    MEDICAL DEVICE RECALL
             BROACH HANDLE MANUFACTURED BY ZIMMER TRABECULAR METAL
                    TECHNOLOGY - USED IN TM-400 SPINAL SURGERY
                                                               May 6, 2009


 INTENDED                            Zimmer Spine Sales Force & Distributors
 AUDIENCE
                     Risk Managers at User Facilities Who are TM-400 Implant System
                                               Customers
                    Name of                                          Part Number
  PRODUCT           Product
                                                            Part Number 96-210-10001
                   BROACH
                   HANDLE                                                All Lots

               The Broach Handle may fracture at the threaded tip during use, leaving the broach or trial in the
REASON FOR     surgical site. Once the Broach Handle has broken, other handles cannot thread onto the
RECALL         broach or trial left in the surgical site.

               Fractures of the broach handle may be associated with:
                       Broaches or Trials not tightly threaded onto the Broach Handle during use
                       Use of levering or a “joystick” motion. This levering is most often associated with
                       attempted use in a space that has not been adequately distracted


                Intervention measures would be required to retrieve the broach or trial left in the vertebral
CLINICAL       space. This could lead to a minor to moderate surgical delay or injury to the patient or
IMPLICATIONS   physician.
(Risks to      The efforts to retrieve the broach or trial could increase the risk of damage to surrounding bone,
Health)        soft tissues or vessels. Damage to tissues may require additional surgical intervention to repair
               the damage, depending on the tissue or vessel damaged.

               Zimmer Spine Distributors and Sales force
ACTION
               Recall of the Broach Handle will be accomplished by quarantining and returning all TM-
               400 Broach Handles P/N 96-210-10001 and the associated Instrument Sets to the local
               country representative.:
                     96-267-40001,
                     96-267-30001,
                     96-267-50001

               The local country office will destroy the Broach Handles P/N 96-210-10001 on site.

               Note: Recall of the Broach Handle will mean that TM-400 surgeries will cease until a
               suitable replacement handle has been developed.

                1. Stop using the device and quarantine it immediately.
                2. Please carry out a physical count of all affected product in your territory and
                  URGENT: FIELD SAFETY NOTICE
                    MEDICAL DEVICE RECALL
              BROACH HANDLE MANUFACTURED BY ZIMMER TRABECULAR METAL
                     TECHNOLOGY - USED IN TM-400 SPINAL SURGERY
                                                                May 6, 2009

                     record the physical destruction of the Broach Handle 96-210-10001on the
                     Inventory Return Certification Form with this letter.
                 3. Fax a copy of the completed Inventory Return Certification form (Page 3) to:
                           Zimmer Spine. at 952-857-5846 or 952-832-5620
                   .




OTHER            Notifications of this correction are being sent to all affected direct accounts of Zimmer
                 Spine. For shipping assistance, questions or assistance in notifying your accounts about
INFORMATION      the recall please contact Zimmer Spine at 800-777-7505


                 Zimmer Spine is committed to providing our customers with the highest level of service and
                 product quality. We appreciate your cooperation, and we regret any inconvenience this action
                 may cause your hospital and your staff.

                 This voluntary correction will be reported to the U.S. Food and Drug Administration.
                 The FDA will also receive from Zimmer progress reports on the implementation of this
                 action. Your urgent cooperation is requested.
                      URGENT: FIELD SAFETY NOTICE
                        MEDICAL DEVICE RECALL
                BROACH HANDLE MANUFACTURED BY ZIMMER TRABECULAR METAL
                       TECHNOLOGY - USED IN TM-400 SPINAL SURGERY
                                                                  May 6, 2009




                            Distributor Certification Form
                        Fax back to: Zimmer Spine at 952-857-5846 or 952-832-5620

    Use the table below to record quantities of the affected product in your territory.

                  Part Number                  Lot Number              Quantity Returned

                 96-210-10001                    All Lots


    Acknowledgement of Responsibility:
    By signing below, I acknowledge that all TM400 Broach Handles P/N 96-210-10001 and all the
    associated TM400 instrument sets containing the 96-210-10001 have been quarantined and the
    Broach Handle 96-210-10001 has been destroyed.


Printed Name:_____________________ Signature:___________________________________

Title _________________________ Telephone: (       ) ______-_______ Date:____/____/____

Territory Number: ____________________Account Number: ______________________

Account Name: _____________________________________________________________

Account Address: __________________________________________________________

								
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