Device product

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

Z-1671-2025

April 17, 2025

Class II

Product summary

Firm: Straumann USA LLC
Event: Event 96726
Status: Ongoing
Classification: Class II
Quantity: 1,786 units
Official record key: device-enforcement:Z-1671-2025

Official wording

Reason: Incorrect blister labelling.

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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Incorrect blister labelling.