International safety notice

Among the SB fixes, foreign objects were found in the inner packaging sterilization bag of SB fix 100mm (made of titanium alloy). was reported by a medical institution. It turned out to be part of. After checking the manufacturing records related to the manufacturing process of the product, we found that the machine that does not originally perform assembly work in the assembly work process. It is assumed that the processing worker was in charge of the assembly process on a temporary basis, and the metal pieces got into the implant during that process. Masu. Since we cannot deny the possibility that metal pieces may have been mixed into the lot where the work was performed, we have decided to carry out a voluntary recall. did. To date, there have been no reports of foreign substance contamination other than this case.

Japan / PMDA Recalls · JPN · Sep 25, 2023