Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to p
FDA device recall Z-1311-2020 · posted 2020-02-19 · Terminated
Recall details
- Recalling firm
- Nobel Biocare Usa Llc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- DZI
- Quantity affected
- 264 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,
- Date initiated
- 2019-03-14
- Date posted
- 2020-02-19
- Date terminated
- 2024-02-15
- Location
- Yorba Linda, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMORPHOUS DIAMOND COATED DRILL (K990846) | Nobel Biocare Uas, Inc. | 1999-06-10 |