FDA recall Z-1461-2023

Baxter Healthcare Corporation · Class II · device

Product

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

Worldwide distribution - US Nationwide and the countries of China, Germany, Sweden, Norway, Netherlands, Greece, Switzerland, France

Key facts

Status
Ongoing
Initiation date
2023-03-27
Report date
2023-05-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1461-2023