Straumann USA LLC: Medical Device Recall in 2025 - (Recall #: Z-1671-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.

Product Classification:

Class II

Date Initiated: April 17, 2025

Date Posted: April 30, 2025

Recall Number: Z-1671-2025

Event ID: 96726

Reason for Recall:

Incorrect blister labelling.

Status: Ongoing

Product Quantity: 1,786 units

Code Information:

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).

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden.

Voluntary or Mandated:

Voluntary: Firm initiated