Zimmer Dental Inc: 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.

Agency Publication Date: February 9, 2016

Affected Products

Product: IMPLANT,TM, MTX 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMM4B10 Product Usage: 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.

Lot # 63192993 63216163

Lot Numbers:

63192993

Product: IMPLANT,TM, MTX 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMM4B11 Product Usage: 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.

Lot # 63192991 63207953

Lot Numbers:

63192991

Product: IMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMM4B13 Product Usage: 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.

Lot # 63203121 63207952 63216164

Lot Numbers:

63203121

Product: 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.

Lot # 63193919 63212189

Lot Numbers:

63193919

Product: IMPLANT,TM, MTX 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMMB11 Product Usage: 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.

Lot # 63212190

Lot Numbers:

63212190

Product: IMPLANT,TM, MTX 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMMB13 Product Usage: 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.

Lot # 63216838

Lot Numbers:

63216838

Product: IMPLANT,TM, MTX FULL 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMT4B10 Product Usage: 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.

Lot # 63187148 63192992 63212188 63216161

Lot Numbers:

63187148

Product: IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11 Product Usage: 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.

Lot # 63192990 63203112 63236810

Lot Numbers:

63192990

Product: IMPLANT,TM, MTX FULL 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMT4B13 Product Usage: 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.

Lot # 63203119 63207951 63232552

Lot Numbers:

63203119

Product: IMPLANT,TM, MTX FULL 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMTB10 Product Usage: 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.

Lot # 63193918 63223934

Lot Numbers:

63193918

Product: IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMTB11 Product Usage: 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.

Lot # 63193920 63244217

Lot Numbers:

63193920

Product: IMPLANT,TM, MTX FULL 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMTB13 Product Usage: 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.

Lot # 63193921 63236806

Lot Numbers:

63193921

Product: IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 Product Usage: 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.

Lot # 63192173

Lot Numbers:

63192173

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73013

Status: Resolved

Manufacturer: Zimmer Dental Inc

Manufactured In: United States

Units Affected: 13 products (1059; 1059; 1050; 1050; 1059; 1059; 1059; 1059; 1059; 1059; 1059; 1059; 1059)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot # 63192993 63216163

Lot Numbers:

63192993

Lot # 63192991 63207953

Lot Numbers:

63192991

Lot # 63203121 63207952 63216164

Lot Numbers:

63203121

Lot # 63193919 63212189

Lot Numbers:

63193919

Lot # 63212190

Lot Numbers:

63212190

Lot # 63216838

Lot Numbers:

63216838

Lot # 63187148 63192992 63212188 63216161

Lot Numbers:

63187148

Lot # 63192990 63203112 63236810

Lot Numbers:

63192990

Lot # 63203119 63207951 63232552

Lot Numbers:

63203119

Lot # 63193918 63223934

Lot Numbers:

63193918

Lot # 63193920 63244217

Lot Numbers:

63193920

Lot # 63193921 63236806

Lot Numbers:

63193921

Lot # 63192173

Lot Numbers:

63192173