Date Initiated by Firm | March 17, 2021 |
Create Date | April 20, 2021 |
Recall Status1 |
Terminated 3 on May 03, 2023 |
Recall Number | Z-1440-2021 |
Recall Event ID |
87626 |
510(K)Number | K141953 K183557 K192018 |
Product Classification |
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
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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. |
Code Information |
GTIN 00191375013167, Lot Number TM0126572 |
Recalling Firm/ Manufacturer |
Medtronic Sofamor Danek USA, Inc 4340 Swinnea Rd Memphis TN 38118-6603
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For Additional Information Contact | Victor Rocha 901-399-2401 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | Packaging process control |
Action | 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. |
Quantity in Commerce | 11 devices |
Distribution | US Nationwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MAX 510(K)s with Product Code = MAX
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