Recall Z-2529-2018 ยท NHA Abutment, Implant, Dental, Endosseous
Nobel Biocare Usa Llc
Nobel Biocare 17 Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous implants, are indicated for multiple unit reconstructions when screw retrained prosthetics are preferred.
| Date | Jul 23, 2018 (initiated Mar 16, 2018) |
| Status | Terminated |
| Reason | The product label has missing information, such as the lot number and expiration date, as well as other information. |
| Root cause | Nonconforming Material/Component |
| Action | Nobel Biocare sent an Urgent Quality Message letter dated March 13, 2018 via email to the U.S. consignees. The letter identified the affected product, problem and actions to be taken. For question contact customer service department at 800-322-5001. |
| Quantity | 74 units were distributed to the U.S. |
| Distribution | Worldwide Distribution - US Nationwide in AR, CA, CO, DC, FL, IL, IN, KS, MD, MI, NE, NJ, NY, ND, OH, OK, PA, SC, TX, VA, WA, WI, and WY. Foreign distribution was made to Austria, France, Germany, Hong Kong, Italy, Japan, Lebanon, Mexico, Spain, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072570 | NOBELACTIVE MULTI UNIT ABUTMENT Nobel Biocare AB, Dec 28, 2007 |