WB XL Anatomic Healing Abutment XC. Endosseous Dental recall: Labeling Error
WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Why was WB XL Anatomic Healing Abutment XC. Endosseous Dental recalled?
Incorrect blister labelling.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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).
- Product
- WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
- Recalling firm
- Straumann USA LLC
- Quantity
- 1,786 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden.
- Recall date
- April 30, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)