Recall Z-0777-2016— Zimmer Dental Inc
Class II · Terminated
Class II FDA medical device recall by Zimmer Dental Inc, initiated 2016-01-06, terminated 2016-05-06. It names one FDA 510(k) clearance: K112160. 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.. Reason: 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..
- Recalling firm
- Zimmer Dental Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-06
- Terminated
- 2016-05-06
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.