The Recall Desk
LowFDA (Devices)·Z-1671-2025·Announced 2025-04-30

Straumann WB XL Anatomic Healing Abutment XC Dental Implants

Straumann USA LLC is recalling 1,786 units of WB XL Anatomic Healing Abutment XC endosseous dental implant abutments due to incorrect blister labeling. The product was distributed worldwide.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall involves incorrect blister labeling only, which is a packaging and documentation issue with no indication of patient harm or safety risk. Per the rubric, labeling errors without health consequences are classified as Low (score 1).

Plain-English summary

Straumann USA LLC is recalling 1,786 units of WB XL Anatomic Healing Abutment XC endosseous dental implant abutments (Article No. 064.4522S and 064.4523S) due to incorrect blister labeling. The affected product was distributed worldwide, including the US nationwide and to Belgium, Canada, China, Netherlands, and Sweden.

Multiple lot numbers are included in the recall: GNNA2 (expiration 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).

Patients or healthcare providers who have this product should contact Straumann USA LLC for guidance on return or replacement. The FDA classified this as a Class II recall (FDA recall number Z-1671-2025).

The recalled product

Product
WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Manufacturer
Straumann USA LLC
Category
Medical Device — Dental Implants / Abutments
Hazard
  • labeling-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • 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

Distributed nationwide across the United States.

Related recalls

Same category