Recall Z-1856-2020 ยท DZE Implant, Endosseous, Root-Form
Nobel Biocare Usa Llc
Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained crowns are used; catalog no. 38214 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
| Date | Aug 9, 2019 |
| Status | Terminated |
| Reason | Packages of abutments (universal base) may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw. |
| Root cause | Process control |
| Action | Urgent Medical Device Recall Letters were sent to U.S. customers via the U.S Postal Service and OUS customers via email beginning on August 9, 2019. This communication notified customers that the firm had identified a packaging issue affecting six product codes and a total of 7 lots of medical devices (titanium abutments) where the packages of abutment lots may contain an incorrect screw. Customers were informed that while the screw will tighten, it cannot be guaranteed that the screw will not loosen. If the screw loosens, customers are instructed to retighten the abutment with the correct |
| Quantity | 238 pieces |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AZ, AR, CA, CO, FL, GA, IL, IN, ID, KS, LA, MI, MD, ME, MA, MO, NY, NC, NJ, NE, NM, OH, OR, OK, PA, TX, TN, VA, WY, WA and WI. Countries of CA, CH, DE, ES, FR, GB, HU, IT, BR, CO, MX, CN, HK, IN, JP and TW. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925762 | BRANEMARK SYSTEM SELF-TAPPING FIXTURE Nobelpharma USA, Inc., Oct 12, 1993 |