Date Initiated by Firm | October 25, 2019 |
Create Date | December 03, 2019 |
Recall Status1 |
Terminated 3 on April 30, 2020 |
Recall Number | Z-0595-2020 |
Recall Event ID |
84224 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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Product | Biomet Orthopedics Intramedullary Bone Saw Cam Assembly
14MM-
Orthopedic manual surgical instrument
Item Number: 475665 |
Code Information |
Lot Numbers: 334360, 366680, 366670 UDI: (01)00880304386587(17)280805(10)334360 (01)00880304386587(17)280530(10)366680 (01)00880304386587(17)280530(10)366670 |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
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For Additional Information Contact | 411 Technical Services 574-371-3071 |
Manufacturer Reason for Recall | Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam
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FDA Determined Cause 2 | Error in labeling |
Action | Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL letter via FedEx and email on 10/25/19. The letter identifies the reason for recall, health risk and action to take: Review this notification and ensure that affected personnel are aware of the contents. 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. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. Questions call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, your questions may be emailed to corporateQuality.PostMarket@zimmerbiomet.com. |
Quantity in Commerce | 34 units |
Distribution | Distribution to US states of CA, FL, IN, MN, MO, NY, and UT, Australia, and New Zealand |
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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