The FDA dinged the device maker over "certain manufacturing and validation processes pertaining to Trilogy acetabular system products," according to the company.
"Specifically, the FDA noted that the company had not implemented a testing mechanism to demonstrate that Trilogy products manufactured at the Ponce facility met certain pre-determined design specifications," Zimmer reported. "The agency also noted that the company had not validated the effect of certain manufacturing operations on Trilogy products manufactured in Ponce that incorporate metallic spikes."
Zimmer is not conducting a recall, but has temporarily suspended distribution from the Puerto Rican facility and is executing a "field action" to notify customers of the issue.
The facility will reopen "within the next few weeks," once the FDA-cited processes have been validated, the company said.