URGENT MEDICAL DEVICE FIELD SAFETY NOTICE- REMOVAL

Transcription

1 January 15, 2018 To: Subject: Reference: Surgeons / Hospitals URGENT MEDICAL DEVICE FIELD SAFETY NOTICE- REMOVAL ZFA Affected Product: ACE Trochanteric Nail (ATN) System See Attachment 2 Affected Product List Zimmer Biomet is conducting a medical device field safety notice (removal) for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system. Risks Describe immediate health consequences (injuries or illness) that may result from use of or exposure to the product issue. Describe long range health consequences (injuries or illness) that may result from use of or exposure to the product issue. Most Probable None Most Probable None Highest Severity None Highest Severity Secondary reduction loss or lateral sliding of the screw resulting in a revision surgery. Screw cut-out resulting in a total hip arthroplasty or revision surgery. Our records indicate that you may have received one or more of the affected products. The affected units were distributed by Zimmer Biomet between July 2012 and December These products were previously distributed by the company Depuy. Surgeons/ Hospitals Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to fieldaction.emea@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. CF04108 Rev.3, Eff. Date: 05 Sep 2017 Ref. CP04102 Field Action Activities Page 1 of 8

2 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 5. If you have further questions or concerns after reviewing this notice, please contact your Zimmer Biomet representative. Other Information This voluntary medical device Field Safety Notice was reported to all relevant Competent Authorities and the related Notified Body as required under the applicable regulations for Medical Devices. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by ing product.experience@zimmerbiomet.com or to your local Zimmer Biomet contact. The undersigned confirms that this notice has been delivered to the appropriate Competent Authorities, as per MEDDEV revision 8. We would like to thank you for your co-operation in advance. Sincerely, CF04108 Rev.3, Eff. Date: 05 Sep 2017 Ref. CP04102 Field Action Activities Page 2 of 8

3 ATTACHMENT 1 Certificate of Acknowledgement IMMEDIATE RESPONSE REQUIRED TIME SENSITIVE ACTION NEEDED Affected Product: ACE Trochanteric Nail (ATN) System Field Action Reference: Please check one as applicable: Hospital Facility Do you have affected product in your facility? (Hospital Facility Only: Please mark the appropriate response.) Yes, we currently have one or more affected items in our facility. No, we currently have no affected items in our facility. By signing below, I acknowledge that the required actions have been taken in accordance with this field safety notice. Printed Name: Signature: Title: Telephone: ( ) - Date: / / Facility Name: Facility Address: City: ZIP: Country: Note: This form must be returned to Zimmer Biomet before this action is closed for your account. It is important that you complete this form and a copy to fieldaction.emea@zimmerbiomet.com CF04108 Rev.3, Eff. Date: 05 Sep 2017 Ref. CP04102 Field Action Activities Page 3 of 8

4 ATTACHMENT 2 Affected Product List All ACE TROCH NAIL 125 DEG. X 11MM All ACE TROCH NAIL 130 DEG. X 11MM All ACE TROCH NAIL 135 DEG. X 11MM All ACE TROCH NAIL 125 DEG. X 13MM All ACE TROCH NAIL 130 DEG. X 13MM All ACE TROCH NAIL 135 DEG. X 13MM All STER TROC END CAP All STER TROC END CAP 5 MM All STER TROC END CAP 10MM All STER TROC END CAP 15 MM All STER TROC END CAP 20 MM All STER TROC END CAP 25 MM All STER TROC NAIL 125 DEG X 9MM All STER TROC NAIL 130 DEG X 9MM All STER TROC NAIL 135 DEG X 9MM All STER TROC LAG SCR 70 MM All TROCH NAIL ST 11X DG STRL All TROCH NAIL ST 11X DG STRL All TROCH NAIL ST 11X DG STRL All STER TROC NAIL 180X11X All STER TROC NAIL 125 DEG X 11MM All STER TROC NAIL 130 DEG X 11MM All STER TROC NAIL 135 DEG X 11MM All TROCH NAIL ST 13X DG STRL All TROCH NAIL ST 13X DG STRL All TROCH NAIL ST 13X DG STRL All STER TROC NAIL 180X13X All STER TROC NAIL 125 DEG X 13MM All STER TROC NAIL 130 DEG X 13MM All STER TROC NAIL 135 DEG X 13MM All ATN AR SCREW 60MM STERILE All ATN AR SCREW 65MM STERILE All ATN LAG SCREW 60MM STERILE All ATN LAG SCREW 65MM STERILE All ATN LAG SCREW 70MM STERILE All ATN LAG SCREW 75MM STERILE CF04108 Rev.3, Eff. Date: 05 Sep 2017 Ref. CP04102 Field Action Activities Page 4 of 8

5 All ATN LAG SCREW 80MM STERILE All ATN LAG SCREW 85MM STERILE All ATN LAG SCREW 90MM STERILE All ATN LAG SCREW 95MM STERILE All ATN LAG SCREW 100MM STERILE All ATN LAG SCREW 105MM STERILE All ATN LAG SCREW 110MM STERILE All ATN LAG SCREW 115MM STERILE All ATN LAG SCREW 120MM STERILE All ATN LAG SCREW 125MM STERILE All ATN LAG SCREW 130MM STERILE All STER L H TROC NAIL 320X9X All STER L H TROC NAIL 340X9X All STER L H TROC NAIL 360X9X All STER L H TROC NAIL 380X9X All STER L H TROC NAIL 400X9X All STER L H TROC NAIL 420X9X All STER L H TROC NAIL 440X9X All STER L H TROC NAIL 460X9X All STER L H TROC NAIL 320X11X All STER L H TROC NAIL 340X11X All STER L H TROC NAIL 360X11X All STER L H TROC NAIL 380X11X All STER L H TROC NAIL 400X11X All STER L H TROC NAIL 420X11X All STER L H TROC NAIL 440X11X All STER L H TROC NAIL 460X11X All STER L H TROC NAIL 320X13X All STER L H TROC NAIL 340X13X All STER L H TROC NAIL 360X13X All STER L H TROC NAIL 380X13X All STER L H TROC NAIL 400X13X All STER L H TROC NAIL 420X13X All STER L H TROC NAIL 440X13X All STER L H TROC NAIL 460X13X All STER R H TROC NAIL 320X9X All STER R H TROC NAIL 340X9X All STER R H TROC NAIL 360X9X All STER R H TROC NAIL 380X9X125 CF04108 Rev.3, Eff. Date: 05 Sep 2017 Ref. CP04102 Field Action Activities Page 5 of 8

6 All STER R H TROC NAIL 400X9X All STER R H TROC NAIL 420X9X All STER R H TROC NAIL 440X9X All STER R H TROC NAIL 460X9X All STER R H TROC NAIL 320X11X All STER R H TROC NAIL 340X11X All STER R H TROC NAIL 360X11X All STER R H TROC NAIL 380X11X All STER R H TROC NAIL 400X11X All STER R H TROC NAIL 420X11X All STER R H TROC NAIL 440X11X All STER R H TROC NAIL 460X11X All STER R H TROC NAIL 320X13X All STER R H TROC NAIL 340X13X All STER R H TROC NAIL 360X13X All STER R H TROC NAIL 380X13X All STER R H TROC NAIL 400X13X All STER R H TROC NAIL 420X13X All STER R H TROC NAIL 440X13X All STER R H TROC NAIL 460X13X All STER L H TROC NAIL 320X11X All STER L H TROC NAIL 320X9X All STER L H TROC NAIL 340X9X All STER L H TROC NAIL 360X9X All STER L H TROC NAIL 380X9X All STER L H TROC NAIL 400X9X All STER L H TROC NAIL 420X9X All STER L H TROC NAIL 440X9X All STER L H TROC NAIL 460X9X All STER L H TROC NAIL 340X11X All STER L H TROC NAIL 360X11X All STER L H TROC NAIL 380X11X All STER L H TROC NAIL 400X11X All STER L H TROC NAIL 420X11X All STER L H TROC NAIL 440X11X All STER L H TROC NAIL 460X11X All STER L H TROC NAIL 320X13X All STER L H TROC NAIL 340X13X All STER L H TROC NAIL 360X13X130 CF04108 Rev.3, Eff. Date: 05 Sep 2017 Ref. CP04102 Field Action Activities Page 6 of 8

7 All STER L H TROC NAIL 380X13X All STER L H TROC NAIL 400X13X All STER L H TROC NAIL 420X13X All STER L H TROC NAIL 440X13X All STER L H TROC NAIL 460X13X All STER R H TROC NAIL 320X9X All STER R H TROC NAIL 340X9X All STER R H TROC NAIL 360X9X All STER R H TROC NAIL 380X9X All STER R H TROC NAIL 400X9X All STER R H TROC NAIL 420X9X All STER R H TROC NAIL 440X9X All STER R H TROC NAIL 460X9X All STER R H TROC NAIL 320X11X All STER R H TROC NAIL 340X11X All STER R H TROC NAIL 360X11X All STER R H TROC NAIL 380X11X All STER R H TROC NAIL 400X11X All STER R H TROC NAIL 420X11X All STER R H TROC NAIL 440X11X All STER R H TROC NAIL 320X13X All STER R H TROC NAIL 340X13X All STER R H TROC NAIL 360X13X All STER R H TROC NAIL 380X13X All STER R H TROC NAIL 400X13X All STER R H TROC NAIL 420X13X All STER R H TROC NAIL 440X13X All STER R H TROC NAIL 460X13X All STER L H TROC NAIL 320X9X All STER L H TROC NAIL 340X9X All STER L H TROC NAIL 360X9X All STER L H TROC NAIL 380X9X All STER L H TROC NAIL 400X9X All STER L H TROC NAIL 420X9X All STER L H TROC NAIL 440X9X All STER L H TROC NAIL 460X9X All STER L H TROC NAIL 320X11X All STER L H TROC NAIL 340X11X All STER L H TROC NAIL 360X11X135 CF04108 Rev.3, Eff. Date: 05 Sep 2017 Ref. CP04102 Field Action Activities Page 7 of 8

8 All STER L H TROC NAIL 380X11X All STER L H TROC NAIL 400X11X All STER L H TROC NAIL 420X11X All STER L H TROC NAIL 440X11X All STER L H TROC NAIL 460X11X All STER L H TROC NAIL 320X13X All STER L H TROC NAIL 340X13X All STER L H TROC NAIL 360X13X All STER L H TROC NAIL 380X13X All STER L H TROC NAIL 400X13X All STER L H TROC NAIL 420X13X All STER L H TROC NAIL 440X13X All STER L H TROC NAIL 460X13X All STER R H TROC NAIL 320X13X All STER R H TROC NAIL 340X13X All STER R H TROC NAIL 360X13X All STER R H TROC NAIL 380X13X All STER R H TROC NAIL 400X13X All STER R H TROC NAIL 420X13X All STER R H TROC NAIL 440X13X All STER R H TROC NAIL 460X13X All STER R H TROC NAIL 320X9X All STER R H TROC NAIL 340X9X All STER R H TROC NAIL 360X9X All STER R H TROC NAIL 380X9X All STER R H TROC NAIL 400X9X All STER R H TROC NAIL 420X9X All STER R H TROC NAIL 440X9X All STER R H TROC NAIL 460X9X All STER R H TROC NAIL 320X11X All STER R H TROC NAIL 340X11X All STER R H TROC NAIL 360X11X All STER R H TROC NAIL 380X11X All STER R H TROC NAIL 400X11X All STER R H TROC NAIL 420X11X All STER R H TROC NAIL 440X11X All STER R H TROC NAIL 460X11X135 CF04108 Rev.3, Eff. Date: 05 Sep 2017 Ref. CP04102 Field Action Activities Page 8 of 8