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

[pending] WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.

Pending LLM rewrite. Source: FDA_DEVICE Z-1671-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Incorrect blister labelling.

The recalled product

Product
WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Manufacturer
Straumann USA LLC
Category
Medical Device — Devices

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