Straumann USA LLC: WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.

Hazard

Incorrect blister labelling.

Details from the source

Reason for recall: Incorrect blister labelling. Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden. Quantity: 1,786 units Lot/code info: 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).

UPC codes

07630031775856, 07630031775863

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.