Reported Oct 29, 2014 · Terminated
Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental…
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?
- Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿
- Loxim Article Number021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery
- Lot codes and dates
- Lot numberGY030 Exp. 2019-04
- Amount recalled
- 6 units
Where it was sold
Why it was recalled
Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
This product could cause temporary or reversible health problems — stop using it.
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