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 for use in the maxilla or mandible for immediate loading or for loading after a conve
Check against the official notice below — it lists the full affected range.
Zimmer Dental Inc. is recalling 299 units of Tapered Screw-Vent Implant System dental implants because the inner package labeling contains incorrect item numbers, lot numbers, and size information, while the correct information appears on the outer package labeling. The affected implants have outer package lot number 63781164 and inner package lot number 63773888, and were distributed nationwide across 20 U.S. states as well as to Australia, Bulgaria, Canada, Croatia, France, Germany, Italy, Portugal, and Spain.
The recall notice does not specify a remedy or recommended action for consumers who may have received this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Quantity: 299 units Lot/code info: Outer Package Label: LOT: 63781164, UDI: (01) 00889024019621 (10) 63781164 (17) 220930 (10) 63781164; Inner Package Label: LOT: 63773888, UDI: (01) 00889024019508 (17) 220930 (10)63773888.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.