Z-0775-2016 Class II Terminated
FDA device recall Z-0775-2016 was initiated by Zimmer Dental Inc on January 6, 2016 and is designated Class II. Reason for recall: Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precaution… The recall status is terminated (terminated May 6, 2016). Affected quantity: 1050.
Recall Details
- Product Type
- Devices
- Report Date
- February 17, 2016
- Initiation Date
- January 6, 2016
- Termination Date
- May 6, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1050
Product Description
IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
Reason for Recall
Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
Distribution Pattern
Worldwide Distribution. US Nationwide in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy
Code Information
Lot # 63193919 63212189