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U.S. Department of Health and Human Services

Class 2 Device Recall Insignia" Anterior Cervical Plate System

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  Class 2 Device Recall Insignia" Anterior Cervical Plate System see related information
Date Initiated by Firm April 26, 2021
Create Date June 07, 2021
Recall Status1 Terminated 3 on November 17, 2022
Recall Number Z-1803-2021
Recall Event ID 87887
510(K)Number K200995  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
Product Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460
Code Information 8609305R
Recalling Firm/
Manufacturer		 Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad CA 92008-6505
For Additional Information Contact Alphatec
1800-922-1356
Manufacturer Reason
for Recall		 There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
FDA Determined
Cause 2		 Under Investigation by firm
Action Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: ¿ Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez ¿ Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Quantity in Commerce 10 units
Distribution US Nationwide distribution in the states of FL, CA, IL, OK, TX, CT, IN, NC, WA, HI, ID, MA, SC, NM, and NY.
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 = KWQ and Original Applicant = Alphatec Spine, Inc.
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