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Smith & Nephew, Inc. recalls JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial
Recalled June 3, 2020 · FDA recall Z-2133-2020 · Smith & Nephew
Hazard
The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble. · FDA Class II
Units
195 units
Sold at
US Nationwide distribution.
Description
The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
Product
JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional moveable spikes (spike rail) aids in provisional fixation of the trial. SIZE 1, CATALOG NUMBER: REF 74035831 SIZE 2, CATALOG NUMBER: REF 74035832 SIZE 3, CATALOG NUMBER: REF 74035833 SIZE 4, CATALOG NUMBER: REF 74035834 SIZE 5, CATALOG NUMBER: REF 74035835 SIZE 6, CATALOG NUMBER: REF 74035836 SIZE 7, CATALOG NUMBER: REF 74035837 SIZE 8, CATALOG NUMBER: REF 74035838 SIZE 9, CATALOG NUMBER: REF 74035839 SIZE 10, CATALOG NUMBER: REF 74035840
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →