FDA Device recall Z-1461-2023
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012
- FDA Device
- Class II
- ongoing
- Published 2023-05-03
On 2023-05-03 the FDA classified a Class II recall of GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012 by Baxter Healthcare, citing the product is brittle and potentially crumbling upon handling or when being removed from its package.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1461-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-27 |
| Published | 2023-05-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
Reason
The product is brittle and potentially crumbling upon handling or when being removed from its package.
Identifiers
| code_info | a) 5311-01240-010, Lot Number 19012112, exp. 12/31/2023; b) 5311-01240-012, Lot Number 19012112, exp. 12/31/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1461-2023%22
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