Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
FDA Recall Z-1303-2020 · Posted 2020-02-19
Recalling FirmNobel Biocare Usa Llc
Recall StatusTerminated
Product CodeDZi
Date Initiated2019-03-14
Date Terminated2024-02-15
Product Quantity8 units
Reason for Recall
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.
Firm 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 instructions provided in this Recall Letter and return the attached Customer Reply Form to the firm via email or fax at 714- 282-5073.
Root Cause
Packaging process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.