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DePuy Orthopaedics, Inc. Recall 89240

Description: GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100

DePuy Orthopaedics, Inc. Recall 89240 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0490-2022
Event ID89240
Event DescriptionGLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.
Quantity140 units
Recall ReasonStems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Device Classification20220119
Device Code InfoLot #: 9793946, 9793947, 9802315, 9802316, 9802317, 9802318, 9802320, 9813856, 9814516, 9824502, 9824503, 9824505, 9834401, 9834402, 9836078, 9841198, 9880972, 9886688, 9887451, 9887452 GTIN: 10603295004189
Center Classification Date20220111
Recall Initiation Date20211207
Recalling FirmDePuy Orthopaedics, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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