GEM NEUROTUBE Nerve Repair Mesh Recalled for Brittleness and Potential Crumbling
Baxter Healthcare's GEM NEUROTUBE absorbable mesh tube, used for peripheral nerve repair, is recalled because the product is brittle and may crumble when handled or removed from packaging. The recall affects 169 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a confirmed structural defect where the product is brittle and may crumble. While no illnesses or injuries have been reported, this represents a risk-of-harm product as defined in the severity rubric.
Plain-English summary
Baxter Healthcare Corporation is recalling GEM NEUROTUBE, an absorbable woven polyglycolic acid mesh tube intended for peripheral nerve repair. The product is supplied under product codes 5311-01240-010 and 5311-01240-012.
The manufacturer reports that the product is brittle and may crumble when handled or removed from its packaging.
The recall impacts 169 units distributed worldwide, including across the United States and internationally to China, Germany, Sweden, Norway, the Netherlands, Greece, Switzerland, and France. The affected units are Lot Number 19012112, with an expiration date of December 31, 2023.
The recalled product
- Product
- GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Surgical Repair
- Hazard
- Affected units
- 169
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- a) 5311-01240-010
- Lot Number 19012112
- exp. 12/31/2023
- b) 5311-01240-012
Distribution
Distributed nationwide across the United States.
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