—#186416

Product

Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

FDA product code: MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K141953, K183557, K192018
Affected lot / code info: GTIN 00191375013167, Lot Number TM0126572

Why it was recalled

The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.

Root cause (FDA determination)

Packaging process control

Action the firm took

The firm initiated the recall by letter on 03/19/2021, The letter requested that the consignee locate and isolate the impacted product and contact the Medtronic Sales Representative to coordinate the return and replacement of the device.

Recalling firm

Firm: Medtronic Sofamor Danek USA, Inc
Address: 4340 Swinnea Rd, Memphis, Tennessee 38118-6603

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2021-03-17
Terminated: 2023-05-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186416. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.