Recall Z-2963-2018 ยท DZE Implant, Endosseous, Root-Form
Zimmer Dental Inc
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 conventional healing period. Implants may be used to replace one or more missing teeth. Immediate load
| Date | May 10, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Labeling mix-ups |
| Action | The firm, Zimmer Biomet, sent an "Medical Device Recall" notice dated 5/10/2018 via FedEx/UPS courier to its customers. OUS distributors received a "distributor" notice. The notice described the product, problem and actions to be taken. The Customers were instructed to immediately return affected product to Field Action, PM Regulatory Compliance, Zimmer Biomet, 4555 Riverside Dr., Palm Beach Gardens, FL 33410 US and asked to complete and return a Certificate of Acknowledgement. and send to CorporateQuality.PostMarket@zimmerbiomet.com. If you have further questions or concerns, please call |
| Quantity | 299 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111889 | ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT Zimmer Dental, Inc., Dec 6, 2011 |