Carlsbad, CA, United States
Zimmer Dental Inc recalls
2 recalls recorded since 2018, most recently on 10 May 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 May 2018
- Terminated
- 19 August 2020
- Reason
- Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.
- Distribution
- Worldwide Distribution: US (nationwide) in states of: AL, CA, CO, CT, FL, GA, ID, IL, MA, MD, MI, MN, MO, NH, NJ, NY, PA,TN, TX, UT, VA, and WA; and to countries of: Australia, Bulgaria, Canada, Croatia, France, Germany, Italy, Portugal, and Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2963-2018
- Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed
Terminated Class II Medical devices
- Recall started
- 29 November 2017
- Terminated
- 8 February 2019
- Reason
- Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
- Distribution
- Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1189-2018, Z-1190-2018
- Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
- Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.