Recall Z-1008-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1008-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-15

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-09-15, terminated 2018-08-20. It names one FDA 510(k) clearance: K032396. Product: 36MM COCR MODULAR HD -6MM. Reason: One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-09-15
Terminated: 2018-08-20
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K032396 — RINGLOC 36MM LINE AND MODULAR FEMORAL HEADSBiomet, Inc.·cleared 2003-08-21

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

36MM COCR MODULAR HD -6MM

Reason for recall

One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field.

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