FDA Medical Device Recalls (openFDA)
Nobel Biocare Usa Llc: Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - 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. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.
- Recall number
- Z-2250-2020
- Recalling firm
- Nobel Biocare Usa Llc
- Product
- Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - 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. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.
- Status
- Terminated
- Initiated
- 2019-05-28
- Posted
- not on file
- Terminated
- 2021-02-09
- Reason
- Packaged dental implant healing abutments were found to contain the wrong size device.
- Root cause
- Labeling mix-ups
- Action
- On 5/28/2019, the firm mailed "Urgent Medical Device Recall" letters with an acknowledgement forms. The letter instructs the customers to: 1. Identify affected devices in your stock. 2. Do not use affected devices. 3. Complete and return the Customer Acknowledgment Form. 4. Return affected devices. If you require any further information or support, please contact your customer support representative at 1-800-322- 5001 x 1527.
- Quantity
- 234 pieces globally, of which 16 were sent to the US.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of TN, IL, MI, and NY. The countries of AT, RU, BE, DE, GB, NO, PL, PT.
- Lot, serial or model codes
- Lot 13076845
- 510(k) numbers
- ["K071370"]
- PMA numbers
- not on file
- Product code
- DZE
- 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