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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
- Hazard
- Affected units
- 1,786
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.
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