Medical device manufacturer, Zimmer Inc., has provided information regarding a Warning Letter Zimmer received from the San Juan District Office of the Food and Drug Administration (FDA) on 25 September 2012 to the subject Zimmer manufacturing facility.
The Warning Letter was issued following an inspection of the Company's manufacturing facility in Ponce, Puerto Rico in June 2012 (hereinafter referred to as Ponce). The Warning Letter cites concerns relating to certain manufacturing and validation processes of the Trilogy Acetabular System and Trilogy Spike Cup products manufactured at Ponce. Specifically, the FDA noted that Ponce had not implemented a testing mechanism to demonstrate that Trilogy products manufactured at the facility met porous coating product specifications. FDA also noted that Ponce had not validated the effect of certain manufacturing operations on Trilogy products that incorporate metallic spikes.
Following the FDA inspection of the Ponce facility in June 2012, Zimmer implemented a corrective action plan to address observations specific to the product manufacturing and validation process. The Company previously halted temporarily and voluntarily release of the affected products from the Ponce facility pending validation of the processes cited in the Warning Letter. Zimmer has since completed the validation of the Trilogy products that do not incorporate metallic spikes and has resumed release of those products. The Company expects to complete validation of the Trilogy spiked shell products by 30 November 2012.
According to Zimmer, the manufacturer has taken actions to permanently address all the concerns cited by the FDA in the Warning Letter.
For details from FDA, please refer to the following FDA website http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm322601.htm.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 25 October 2012