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U.S. Department of Health and Human Services

Class 2 Device Recall ALTERA Spacer

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  Class 2 Device Recall ALTERA Spacer see related information
Date Initiated by Firm July 22, 2020
Date Posted August 22, 2020
Recall Status1 Terminated 3 on August 19, 2021
Recall Number Z-2856-2020
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, 15¿
Code Information Part #: 1124.1033; Lot # / UDI #: BAX112VE / (01)00889095069556(10)BAX112VE; BAX126AE / (01)00889095069556(10)BAX126AE; BAX126WE / (01)00889095069556(10)BAX126WE; BAX207AE / (01)00889095069556(10)BAX207AE; BAX244KE / (01)00889095069556(10)BAX244KE; BAX264UE / (01)00889095069556(10)BAX264UE; BAX256DE / (01)00889095069556(10)BAX256DE; BAX348DE / (01)00889095069556(10)BAX348DE; BAX351NE / (01)00889095069556(10)BAX351NE
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 and Original Applicant = GLOBUS MEDICAL INC.
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