Class I - Dangerous
The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo.
The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo.
Products were distributed with the incorrect instructions for use.
Products were distributed with the incorrect instructions for use.
There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.