Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.4308 Product Usage: 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. 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
This recall has been terminated (originally issued November 6, 2014).
- Company
- Straumann Usa Llc
- Recall Initiated
- September 24, 2014
- Posted
- November 6, 2014
- Terminated
- June 26, 2017
- Recall Number
- Z-0174-2015
- Quantity
- 111 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)
Distribution
US Nationwide Distribution
Lot / Code Info
Lot number: GY256
Root Cause
Packaging process control
Action Taken
Straumann USA sent a Field Corrective Action Notice letter dated September 24, 2014 and delivered via United Parcel Service. The letter identified the affected product, problem and actions to be taken. Straumann is requesting the return of unused implants. Returns and Customer Confirmation form is to be returned. Contact firm 781-747- 2514.
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