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

Dental Implant Abutments Recalled for Incorrect Blister Labelling

Straumann USA LLC is recalling WB XL Anatomic Healing Abutment XC dental implant abutments worldwide due to incorrect blister labelling that could compromise product identification.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This FDA Class II recall is classified as Moderate due to a minor labeling error affecting product identification, with no reported illnesses or injuries. The hazard is a documentation and labeling issue rather than a functional product defect.

Plain-English summary

Straumann USA LLC is recalling WB XL Anatomic Healing Abutment XC Endosseous Dental Implant Abutments due to incorrect blister labelling. A total of 1,786 units are affected. The recalled abutments were distributed worldwide, including in the United States, Belgium, Canada, China, Netherlands, and Sweden.

The recall addresses incorrect labelling on product blisters. No illnesses or injuries have been reported in connection with this issue.

Users of affected abutments should stop using the product and contact Straumann USA LLC for return or replacement instructions. Affected lot numbers and expiration dates are detailed in the FDA recall notice. Verification of affected units can be performed using the lot numbers and UDI codes referenced in the official recall notification.

The recalled product

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

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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