(b)(4).Concomitant medical products - avantage thread shaft straight, ref: 110027769, lot : 120200.This follow-up report is being submitted to relay additional information.The device manufacturing quality record could not be reviewed as the item and lot number of the product were not communicated.Complaint sample was evaluated and investigation on the product did not show any non-conform results.The investigation showed that the most likely root cause of the event is the design of the associated item avantage thread shaft straight, ref: 110027769, lot: 120200 (handled in the complaint (b)(4)).Therefore, a corrective action has been initiated to investigate the event, and a recall was performed on the avantage thread shaft straight.Please note that no devices involved in the recall were delivered to the usa.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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