Date Initiated by Firm |
March 15, 2018 |
Create Date |
April 11, 2018 |
Recall Status1 |
Terminated 3 on April 25, 2019 |
Recall Number |
Z-1360-2018 |
Recall Event ID |
79495 |
Product Classification |
Chisel (osteotome) - Product Code KDG
|
Product |
Normed Charcot Osteotome Chisel (Various sizes) |
Code Information |
Models: 26.08.506 OSTEO 8MM AND W/HDL 20CM/8IN 26.08.507 OSTEO 10MM AND W/HDL 20CM/8IN 26.08.508 OSTEO 12MM AND W/HDL 20CM/8IN 26.08.509 OSTEO 13MM CRVD R 10 23CM/9IN 26.08.619 OSTEO 19MM CRVD R 10 23CM/9IN (No US distribution) 26.08.712 OSTEO 12MM CRVD R 6 23CM/9IN (No US distribution) 26.08.715 OSTEO 15MM CRVD R 6 23CM/9IN (No US distribution) 26.08.718 CHARC OSTE 18MM CRD R6 23CM/9 26.08.812 OSTEO 12MM CRVD R 8 23CM/9IN (No US distribution) 26.08.815 OSTEO 15MM CRVD R 8 23CM/9IN (No US distribution) 26.08.818 CHARC OSTE 18MM CRD R8 23CM/9 (No US distribution) 26.08.900 ARTHROPIC ARTH 18CM 45TUFF HDL 26.08.910 RUTREK CHIS 20CM/8 DBL CUT BLD |
Recalling Firm/ Manufacturer |
Zimmer GmbH Sulzerallee 8 Winterthur Switzerland
|
Manufacturer Reason for Recall |
Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
On March 15, 2018 an URGENT MEDICAL DEVICE RECALL LETTER was issued to affected hospitals with the following instructions:
1. Review this notification for awareness of the contents.
2. Assist your Zimmer Biomet sales representative to quarantine immediately all affected instruments.
3. Your Zimmer Biomet sales representative will remove the affected instruments from your facility
Questions or concerns can be directed to a zimmer biomet representative. |
Distribution |
CO, IN, TX, IL |
Total Product Life Cycle |
TPLC Device Report
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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.
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