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Zimmer Biomet (NYSE:ZBH) said it is initiating a part-number specific recall of Persona Trabecular Metal tibial plate instruments and modular brackets.
The company initially recalled its Persona Trabecular Metal tibial implants in February last year due to incidents of radiolucent lines and loosening “higher than Zimmer’s expectation and experience.” Zimmer Biomet said that further investigation indicated that instruments used to prepare for and to perform the implant could be related to the previous recall.
A total of 19 different instrument reference numbers were indicated in the recall, with reference numbers for 8 different modular brackets referenced in each set, according to an urgent field safety notice from the company
The company said that affected sets may cause an implant to not have appropriate initial fixation and cause patient pain, and on the long-term could lead to implants never achieving biological fixation, which could necessitate revision surgery. However, the risks were noted as “worst case” scenarios, and that the most probable outcome would be no adverse events.
