FDA Medical Device Recalls (openFDA)
Straumann USA LLC: WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
- Recall number
- Z-1671-2025
- Recalling firm
- Straumann USA LLC
- Product
- WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
- Status
- Open, Classified
- Initiated
- 2025-04-17
- Posted
- 2025-04-24
- Terminated
- not on file
- Reason
- Incorrect blister labelling.
- Root cause
- Under Investigation by firm
- Action
- An "Urgent Field Safety Action" notification dated 4/17/2025 was mailed to consignees. The notification instructs consignees to immediately check inventory for affected devices and to quarantine any units identified as in stock. Any recalled devices identified are to be returned to Straumann USA LLC to the attention of Jennifer Jackson for credit or replacement. For affected devices that have been implanted, consignees are being instructed to evaluate the compatibility based on the provided instructions. Consignees are asked to return the provided Customer Confirmation Form using the UPS label included in the notification.
- Quantity
- 1,786 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden.
- Lot, serial or model codes
- Article No. 064.4522S and 064.4523S; UDI (01)07630031775856(11)240613(17)290612(10)GNNA2, (01)07630031775856(11)241115(17)291114(10)JZYZ3, (01)07630031775856(11)241216(17)291215(10)KRJA6, (01)07630031775863(11)240604(17)290603(10)GJXT4, (01)07630031775863(11)241011(17)291010(10)JLLP9, (01)07630031775863(11)241120(17)291119(10)KCKL1, (01)07630031775863(11)241211(17)291210(10)KPRE4, (01)07630031775863(11)250219(17)300218(10)LWZM6; Lot No. (Expiration Date): GNNA2 (6/12/29), JZYZ3 (11/14/29), KRJA6 (12/15/29), GJXT4 (6/3/29), JLLP9 (10/10/29), KCKL1 (11/19/29), KPRE4 (12/10/29), and LWZM6 (2/18/30).
- 510(k) numbers
- K241575
- PMA numbers
- not on file
- Product code
- NHA
- Firm FEI
- 1000121052
- Firm city
- Andover
- Firm state
- MA
- 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