Reported Aug 24, 2016 · Terminated
Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
Straumann Manufacturing, Inc.
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 Manufacturing, Inc. · 60 Minuteman Rd · Andover, MA · 01810-1008
Is this the product you have?
- Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr
- NTP Article Number021.4510
- Lot codes and dates
- Lot Numbers
LR810LT122
- Lot Numbers
- Amount recalled
- 70 pieces
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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