Zimmer Biomet, a medical device company, announced that it was initiating a recall of its Persona Trabecular Metal tibial plate instruments and modular brackets.

The Zimmer tibial implant recall instructs physicians to quarantine affected products and to contact the company for product removal. Reports further indicate that the recall announced, issued voluntarily, will be extended and conveyed to local authorities.

The Zimmer tibial implant recall, part-number specific, includes 19 tibial plate instruments and 8 modular brackets. Each instrument and modular bracket includes a reference number as indicated in the recall, the notice from the company announced.

The medical device company had formerly recalled its Persona Trabecular Metal tibial implants in February of last year. Further inquiry, according to Zimmer Biomet, suggests that the instruments and modular brackets being recalled could be associated with the previous recall.

Zimmer Biomet had recalled the instruments and modular brackets last year due to “incidents of radiolucent lines and loosening ‘higher than Zimmer’s expectation and experience,’” the company stated.

The Zimmer tibial implant recall alerts that the tibial plate instruments and modular brackets affected can have short and long-term consequences for their use.

Specifically, such long-term consequences may be that the implant does not achieve biological fixation, an issue requiring revision surgery. And in the short-term, there may be issues in delivering appropriate initial fixation that can cause patient pain.

These risks indicated, however, denote “worst case” scenarios, and no adverse events are deemed or expected to occur, according to the Zimmer tibial implant recall.

The Federal Drug Administration, or FDA, in May, forewarned Zimmer Biomet about “a series of quality system violations” they identified during assessments and re-evaluations made in a Montreal plant in January, the Zimmer tibial implant recall explained.

According to the assessments and forewarnings made, the notice pertained to the company’s iAssist and Zimmer PSI knee systems. It had also included the Zimmer PSI shoulder and Navitrack software system. The letter pertaining to these products was dated May 27 and released June 30.

According to the FDA, “the inspections, from January 25 through January 28, turned up 9 quality system violations that were issued in a Form 483 notice.”

The FDA had also alerted that in the company’s response, dated in February, they had failed to acknowledge a multitude of problems including, “lack of procedures for implementing corrective and preventive actions; ensuring equipment calibration, inspection maintenance; receiving and tracking medical device reports; failing to file correction or removal within 10 business days; and failing to record the reason for not reporting corrections or removals,” the agency said.

Accordingly, the medical device company had also needed a system or method for the “receipt and evaluation” of assessments made and that the company also needed to mandate that its supplies and resources follow federal guidelines, the warning letter stated.

Zimmer Biomet, according to the notice, was further alerted that it did not keep records pertaining to its medical devices and that it failed to carry a system for “quality audits.”