Recall Z-1324-2020 ยท DZE Implant, Endosseous, Root-Form
Nobel Biocare Usa Llc
Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
| Date | Feb 19, 2020 (initiated Mar 14, 2019) |
| Status | Terminated |
| Reason | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. |
| Root cause | Packaging process control |
| Action | On 3/27/2018 the firm issued a recall notice by email to affected consignees. The recall notification informed the following actions to be taken by the consignees: 1. Identify affected devices as detailed in the Customer Reply Form. 2. Do not use affected devices. 3. Send back the Customer Reply Form and the affected devices. The firm will replace affected devices free of charge. This letter needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. We kindly ask you to follow instru |
| Quantity | 7 units |
| Distribution | Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955697 | ABUTMENT RETRIEVAL KIT Nobelpharma USA, Inc., Jan 30, 1996 |