Straumann dental implants recalled for mislabeled length
Straumann USA is recalling one lot of its Bone Level Tapered (BLT) dental implants, 14mm model, because some may actually be 12mm long, which does not match the label. The recall covers 175 units distributed nationwide, and no injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Straumann recalls
What to do
- Check the packaging for lot number ZVFV5 and UDI/DI 7630031707055.
- If you have this lot, contact Straumann USA for return or replacement instructions.
- Do not use any affected implant until you have confirmed its length.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 175 units
- Illnesses reported
- None reported
- Manufactured in
- 60 Minuteman Rd, Andover, MA, United States
- Classification
- Class II
- Recall number
- Z-2935-2026
In the FDA's words
- Description
- Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest. UDI/DI 7630031707055, Lot ZVFV5 Distribution: US Nationwide distribution. Affected quantity: 175 units
- Hazard
- Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.
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