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Recall Observatory FDA recall evidence

Device product

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

Z-0174-2015

September 24, 2014

Class II

Product summary

Firm
Straumann USA, LLC
Event
Event 69454
Status
Terminated
Classification
Class II
Quantity
111 units
Official record key
device-enforcement:Z-0174-2015

Official wording

Reason: Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)

Code information: Lot number: GY256

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)