FDA (Devices) recall action 73013

Zimmer Dental Inc recalled 13 products on 2016-02-17

The FDA (Devices) publishes a recall like this one as 13 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 13 pages.

Products: 13
Announced: 2016-02-17
Critical: 0
Units: 13,749

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–13 of 13

LowFDA (Devices)··2016-02-17
Zimmer Dental Implants Recalled for Omitted Instructions
Zimmer Dental Inc. is recalling specific dental implants because important safety information was missing from the latest instruction manual.
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
Category
Distribution
31 states
ModerateFDA (Devices)··2016-02-17
Zimmer Dental Implants Recalled for Missing Safety Information in Instructions
Zimmer Dental Inc is recalling specific dental implants because the instructions for use omitted safety information regarding the 3.7 mmD and 4.1 mmD Trabecular Metal models.
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 o
Category
Distribution
31 states
ModerateFDA (Devices)··2016-02-17
Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions
Zimmer Dental Inc. is recalling specific Trabecular Metal dental implants because safety information was omitted from the instructions for use.
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 m
Category
Distribution
31 states
ModerateFDA (Devices)··2016-02-17
Zimmer Dental Implants Recalled for Omitted Instructions in Manual
Zimmer Dental Inc. is recalling specific Trabecular Metal dental implants because critical safety information was missing from the instruction manual.
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
Category
Distribution
31 states
ModerateFDA (Devices)··2016-02-17
Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions
Zimmer Dental Inc is recalling specific dental implants because safety information was omitted from the instructions for use.
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 mo
Category
Distribution
31 states
ModerateFDA (Devices)··2016-02-17
Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions
Zimmer Dental Inc. is recalling specific Trabecular Metal dental implants because safety information was omitted from the latest instructions for use.
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
Category
Distribution
31 states
ModerateFDA (Devices)··2016-02-17
Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions
Zimmer Dental Inc is recalling specific Trabecular Metal dental implants because safety information was omitted from the instructions for use.
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 o
Category
Distribution
31 states
LowFDA (Devices)··2016-02-17
Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions
Zimmer Dental Inc. is recalling specific dental implants because safety information was missing from the instructions for use.
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
Category
Distribution
31 states
ModerateFDA (Devices)··2016-02-17
Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions
Zimmer Dental Inc. is recalling specific Trabecular Metal dental implants because safety information was missing from the instructions for use.
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 mor
Category
Distribution
31 states
ModerateFDA (Devices)··2016-02-17
Zimmer Dental Implants Recalled for Missing Instructions
Zimmer Dental Inc. is recalling specific dental implants because the latest instructions omitted information for certain models.
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 mor
Category
Distribution
31 states
ModerateFDA (Devices)··2016-02-17
Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions
Zimmer Dental Inc is recalling specific Trabecular Metal dental implants because safety information was missing from the instructions for use.
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
Category
Distribution
31 states
ModerateFDA (Devices)··2016-02-17
Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions
Zimmer Dental Inc. is recalling specific Trabecular Metal implants because safety information was omitted from the instructions for use.
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
Category
Distribution
31 states
LowFDA (Devices)··2016-02-17
Zimmer Dental Implants Recalled for Missing Instructions in Manual
Zimmer Dental Inc is recalling specific Trabecular Metal implants because the latest instruction manual omitted critical safety information for certain sizes.
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
Category
Distribution
31 states