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Smith & Nephew, Inc. Recall 88975

Description: Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.

Smith & Nephew, Inc. Recall 88975 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0265-2022
Event ID88975
Event DescriptionSmith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
Product TypeDevices
DistributionDistribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and WA. There was no direct government distribution. There was no military distribution. Foreign distribution was made to Australia, Canada, China, Dubai/MENA, Germany, Italy, Japan, Netherlands, Singapore, and Thailand.
Quantity224 units
Recall ReasonThe labels on the packages of screws were switched.
Device Classification20211124
Device Code InfoREF 72413575 - batch #21FM24289; REF 72413570 - batch #21GM04743.
Center Classification Date20211118
Recall Initiation Date20211025
Recalling FirmSmith & Nephew, Inc.
Initial Notification Letter
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