Device recall: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 43mm Item Nu

FDA's record gives the reason for recall as: "Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions."

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

FDA's distribution pattern field reads: "US Nationwide"

FDA lists the status as Terminated; the termination date is 20 May 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.