FDA recall Z-1008-2018

Product

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.

Distribution

Outside USA

Key facts

Status

Terminated

Initiation date

2017-09-15

Report date

2018-03-21

Termination date

2018-08-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1008-2018