Z-1461-2023Class II

GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b)...

Name: Z-1461-2023 GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b)...
Creator: Baxter Healthcare Corporation
Published: 2023-03-27
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2023-03-27 / Open, Classified / root cause: packaging

FDA source

Baxter Healthcare Corporation began a recall of GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair on 2023-03-27. FDA classified it as Class II and gives the reason as "The product is brittle and potentially crumbling upon handling or when being removed from its package". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1461-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-27
Posted: 2023-04-25
Recalling firm: Baxter Healthcare Corporation
Product: GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
Product code: JXI Cuff, Nerve
Reason for recall: The product is brittle and potentially crumbling upon handling or when being removed from its package.
Root cause tag: packaging
FDA root cause: 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
Product codes and lots: a) 5311-01240-010, Lot Number 19012112, exp. 12/31/2023; b) 5311-01240-012, Lot Number 19012112, exp. 12/31/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1461-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1461-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-25

Product code JXI

K983007Class IINeurotubeNeuroregen, LLC / cleared 1999-03-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)