FDA Flags Spate of Repeat Nonconformities at Zimmer Biomet Facility

February 12, 2018

In a rare exception to the FDA’s normal practice, the agency posted a Form 483 flagging several GMP and MDR nonconformities — most of which are repeat observations — at a Zimmer Biomet medical device manufacturing facility in Indiana.

Out of the eight nonconformities the FDA investigators noted, five were first observed during site inspections dating back to 2011 or 2015, with the last one concluding in October 2017. The firm’s CAPA procedures and lack of written MDR procedures are among those flagged on more than one occasion.

A CAPA investigation regarding the use of existing nonconforming products was closed last August after the firm initiated a recall of its Class II hip and Class II/III knee implants to address a customer complaint “alleging that a surgeon opened a femoral implant and found parts of the plastic bag sticking to the implant,” the FDA said. 

In an attempt to correct the problem, the firm acted to replace the implants’ old Low Density Polyethylene bag with a new one for future packaging, and concluded the complaint investigation by stating that “the plastic bag sticking on the implant was the ‘old style poly bag,’” the FDA investigators said. But the “scope of the containment action was not sufficient to correct and prevent the recurrence of the nonconformity.” The issue was first noted in 2011.

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