Recalls / —

—#213466

Product

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

FDA product code

NHA — Abutment, Implant, Dental, Endosseous

Device class

Class 2

Medical specialty

Dental

510(k) numbers

K241575

Affected 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).

Why it was recalled

Incorrect blister labelling.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

An "Urgent Field Safety Action" notification dated 4/17/2025 was mailed to consignees. The notification instructs consignees to immediately check inventory for affected devices and to quarantine any units identified as in stock. Any recalled devices identified are to be returned to Straumann USA LLC to the attention of Jennifer Jackson for credit or replacement. For affected devices that have been implanted, consignees are being instructed to evaluate the compatibility based on the provided instructions. Consignees are asked to return the provided Customer Confirmation Form using the UPS label included in the notification.

Recalling firm

Firm

Straumann USA LLC

Address

60 Minuteman Rd, Andover, Massachusetts 01810-1008

Distribution

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden.

Timeline

Recall initiated

2025-04-17

Posted by FDA

2025-04-24

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #213466. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.