Reported Aug 15, 2012 · Terminated
Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650…
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 Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous
- dental implant Article Number027.2650
- Product UsageDental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a Straumann Narrow CrossFit CARES ZrO2 Abutment in edentulous or partially edentulous patients. 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 a Straumann Narrow CrossFit CARES ZrO2 abutment is attached by screw to the dental implant. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used
- Lot codes and dates
26217US_10008_00_b0025262US_10115_00_b0525262US_10115_00_b0621408US_10073_00_b0126199US _10021_00_b0025143US_ 10215_00_ b0125267US_10278- 00_ b0125267US _10280_ 00_b0125267US_ 1280_ 00_b0325310US_10342_03_b0125310US_10342_03_b0325310US_10342_03_b0525310US_10345_00_b0126249US_10019_00_b01
- Amount recalled
- 14 Distributed in US
Where it was sold
Why it was recalled
Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2
This product could cause temporary or reversible health problems — stop using it.
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