Date Initiated by Firm | July 22, 2020 |
Date Posted | August 22, 2020 |
Recall Status1 |
Terminated 3 on August 19, 2021 |
Recall Number | Z-2853-2020 |
Recall Event ID |
86164 |
510(K)Number | K140411 |
Product Classification |
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
|
Product | ALTERA Spacer
ALTERA Spacer, 10x26, 10-14mm, 8 |
Code Information |
Part #: 1124.1013; Lot # / UDI #: BAX104GE / (01)00889095069495(10)BAX104GE; BAX156GE / (01)00889095069495(10)BAX156GE; BAX156HE / (01)00889095069495(10)BAX156HE; BAX195WE / (01)00889095069495(10)BAX195WE; BAX361LE / (01)00889095069495(10)BAX361LE |
Recalling Firm/ Manufacturer |
Globus Medical, Inc. 2560 General Armistead Ave Audubon PA 19403-5214
|
For Additional Information Contact | Globus Customer Service 866-456-2871 |
Manufacturer Reason for Recall | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | A customer letter dated July 22, 2020 was mailed to customers. In this letter customers are instructed to immediately examine their inventory and determine if they
have any of the affected implants. Alternatively, they may return all ALTERA inventory and Globus will sort out the affected implants and replace inventory with conforming implants. Report any adverse effects believed to be associated with the product to Globus Medical immediately by filling out the attached Response Card. |
Distribution | Worldwide Distribution |
Total Product Life Cycle | TPLC Device Report |
|
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.
|
510(K) Database | 510(K)s with Product Code = MAX
|