Z-1461-2023 Class II Ongoing
FDA device recall Z-1461-2023 was initiated by Baxter Healthcare Corporation on Mar 27, 2023 and is designated Class II. Reason for recall: The product is brittle and potentially crumbling upon handling or when being removed from its package. The recall status is ongoing. Affected quantity: 169 units.
Recall details
- Product Type
- Devices
- Report Date
- May 3, 2023
- Initiation Date
- Mar 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 169 units
Product description
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
Reason for recall
The product is brittle and potentially crumbling upon handling or when being removed from its package.
Distribution pattern
Worldwide distribution - US Nationwide and the countries of China, Germany, Sweden, Norway, Netherlands, Greece, Switzerland, France
Code information
a) 5311-01240-010, Lot Number 19012112, exp. 12/31/2023; b) 5311-01240-012, Lot Number 19012112, exp. 12/31/2023
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1461-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026