Z-1671-2025Class II

WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments

Name: Z-1671-2025 WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments
Creator: Straumann USA LLC
Published: 2025-04-17
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2025-04-17 / Open, Classified / root cause: labeling and UDI

FDA source

Straumann USA LLC began a recall of WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments on 2025-04-17. FDA classified it as Class II and gives the reason as "Incorrect blister labelling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1671-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-17
Posted: 2025-04-24
Recalling firm: Straumann USA, LLC
Product: WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Incorrect blister labelling.
Root cause tag: labeling and UDI
FDA 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 in commerce: 1,786 units
Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1671-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1671-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-24

Product code NHA

K241575Class IIStraumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC / cleared 2024-11-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)