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Medtronic Sofamor Danek USA Inc Recall 88684

Description: Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm

Medtronic Sofamor Danek USA Inc Recall 88684 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0085-2022
Event ID88684
Event DescriptionEndoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Product TypeDevices
DistributionDistribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
Quantity10 units
Recall ReasonEngraving on implants may not match what is listed on the pouch labels.
Device Classification20211020
Device Code InfoProduct Number 2312-0212-N, Lot A200323 GTIN 00191375014171
Center Classification Date20211012
Recall Initiation Date20210902
Recalling FirmMedtronic Sofamor Danek USA Inc
Initial Notification Letter
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