Recall Z-1294-2023— Zimmer, Inc.

Name: FDA recall Z-1294-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-27

Class II · Ongoing

Class II FDA medical device recall by Zimmer, Inc., initiated 2023-02-27. It names one FDA 510(k) clearance: K993259. Product: CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384. Reason: 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.

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-02-27
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K993259 — INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADSSulzer Orthopedics, Inc.·cleared 2000-03-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.