Reported Nov 12, 2014 · Terminated
Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: 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 Implant 04.1 mm RCSLActive¿ 8mmRoxolid¿
- Loxim Article Number021.4308
- Product UsageDental 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. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used
- Lot codes and dates
- Lot numberGY256
- Amount recalled
- 111 units
Where it was sold
- Nationwide
Why it was recalled
Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)
This product could cause temporary or reversible health problems — stop using it.
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