FDA Medical Device Recalls (openFDA)
Nobel Biocare Usa Llc: Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
- Recall number
- Z-1323-2020
- Recalling firm
- Nobel Biocare Usa Llc
- Product
- Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
- Status
- Terminated
- Initiated
- 2019-03-14
- Posted
- 2020-02-19
- Terminated
- 2024-02-15
- 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 instructions provided in this Recall Letter and return the attached Customer Reply Form to the firm via email or fax at 714- 282-5073.
- Quantity
- 87 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.
- Lot, serial or model codes
- 857717 (01)07332747083750(10)857717 28-Dec-2018 857597 (01)07332747083750(10)857597 31-Aug-2018 857656 (01)07332747083750(10)857656 22-Oct-2018 818712 (01)07332747083750(10)818712 9-Nov-2018 818747 (01)07332747083750(10)818747 9-Nov-2018 818647 (01)07332747083750(10)818647 10-Oct-2018 857578 (01)07332747083750(10)857578 23-Aug-2018 857610 (01)07332747083750(10)857610 10-Sep-2018 857615 (01)07332747083750(10)857615 13-Sep-2018 857653 (01)07332747083750(10)857653 10-Oct-2018 857677 (01)07332747083750(10)857677 7-Nov-2018 857694 (01)07332747083750(10)857694 3-Dec-2018 857708 (01)07332747083750(10)857708 14-Dec-2018 857711 (01)07332747083750(10)857711 20-Dec-2018 857729 (01)07332747083750(10)857729 8-Jan-2019 857732 (01)07332747083750(10)857732 15-Jan-2019 818682 (01)07332747083750(10)818682 5-Nov-2018 818811 (01)07332747083750(10)818811 18-Dec-2018 Catalog# 37470
- 510(k) numbers
- ["K990846"]
- PMA numbers
- not on file
- Product code
- DZI
- Firm FEI
- 1000125598
- Firm city
- Yorba Linda
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28