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Terminated

Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm

FDA Recall Z-0086-2022 · Posted None

Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeOVE
Date Initiated2021-09-02
Date Terminated2023-10-05
Product Quantity9 units

Reason for Recall

Engraving on implants may not match what is listed on the pouch labels.

Firm Action

A customer letter was sent via FedEx to impacted US consignees and delivered on or about September 3, 2021. Customers are asked to locate and remove the impacted product from normal storage locations. Customers are advised to not use product. A Customer Confirmation Form should be completed and returned to [email protected]. Customers may also coordinate return and replacement of impacted product with the Medtronic Sales Representative. This recall notice should be forwarded to those within the customer organization or to any organization where potentially impacted devices have been transferred.

Root Cause

Packaging change control

Distribution Pattern

Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion DeviceTitan Spine, Inc. · 2019-08-16K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc. · 2019-08-06K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) DeviceTitan Spine, Inc. · 2019-02-11K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion DeviceTitan Spine, LLC · 2018-02-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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