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U.S. Department of Health and Human Services

Class 2 Device Recall GEM Neurotube

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  Class 2 Device Recall GEM Neurotube see related information
Date Initiated by Firm March 27, 2023
Date Posted April 25, 2023
Recall Status1 Open3, Classified
Recall Number Z-1461-2023
Recall Event ID 91951
510(K)Number K983007  
Product Classification Cuff, nerve - Product Code JXI
Product GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
Code Information a) 5311-01240-010, Lot Number 19012112, exp. 12/31/2023; b) 5311-01240-012, Lot Number 19012112, exp. 12/31/2023
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 The product is brittle and potentially crumbling upon handling or when being removed from its package.
FDA Determined
Cause 2		 Under Investigation by firm
Action Baxter issued an Urgent Medical Device Recall notice to its consignees on 03/27/2023 by mail (USPS). The notice explained the issue and the risk and requested the following actions: 1. Immediately locate, isolate, and cease all use of the affected lot number of the product. 2. Contact Synovis MCA to arrange for return and replacement of the product. Synovis MCA can be reached at 800-510-3318 or 205-941-0111 between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday. Please have your Synovis MCA account number, product code, lot number, and quantity of product to be returned ready when calling. 3. If you received this communication directly from Baxter, please acknowledge receipt by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any inventory. Log in to the portal using the account number listed on the enclosed reply form instruction sheet. 4. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them.
Quantity in Commerce 169 units
Distribution Worldwide distribution - US Nationwide and the countries of China, Germany, Sweden, Norway, Netherlands, Greece, Switzerland, France
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JXI and Original Applicant = NEUROREGEN, L.L.C.
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