Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00889024169074 UDI-DI	Date23 Oct 2017Listed	StatusListed GUDID: in commercial distribution

Recalls

3 recalls · 1 ongoing · FDA

- Ongoing Z-1294-2023 FDA Class II initiated 27 Feb 2023
Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard (ISO 21535:2009
- Terminated Z-1132-2015 FDA Class II initiated 17 Dec 2014
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
- Terminated Z-0222-2013 FDA Class II initiated 4 Sep 2012
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

1 jurisdiction

United States — GUDID listing Listed

GUDID

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