CLASS II ONGOING Device recall · Reported 30 Apr 2025 · FDA Enforcement Report
WB XL Anatomic Healing Abutment XC. Endosseous Dental recalled
Straumann USA is recalling WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments, distributed nationwide in the US. The recall was initiated on 17 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1671-2025
- FDA event ID
- 96726
- Recalling firm
- Straumann USA, Andover, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Apr 2025
- FDA classified
- 24 Apr 2025
- Reported
- 30 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Dental Devices
Timeline
| 17 Apr 2025 | Recall initiated by company | |
| 24 Apr 2025 | Classified by FDA | +7 days |
| 30 Apr 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect blister labelling.
Product as listed by the FDA
WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden.
Questions about this recall
Why was it recalled?
Incorrect blister labelling.
Which lots 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).
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
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