Reported Apr 30, 2025 · Ongoing

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

Straumann USA LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Straumann USA LLC · 60 Minuteman Rd · Andover, MA · 01810-1008

Is this the product you have?

  • WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Lot codes and dates
  • 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)
Amount recalled
1,786 units

Where it was sold

  • Nationwide

Why it was recalled

Incorrect blister labelling.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

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