PlainRecalls
FDA Devices Moderate Class II Terminated

36MM COCR MODULAR HD -6MM

Reported: March 21, 2018 Initiated: September 15, 2017 #Z-1008-2018

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.

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
23
Distribution
Outside USA
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
36MM COCR MODULAR HD -6MM. Recalled by Zimmer Biomet, Inc.. Units affected: 23.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 21, 2018. Severity: Moderate. Recall number: Z-1008-2018.