Device product
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
Z-1461-2023
Product summary
- Event
- Event 91951
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 169 units
- Official record key
device-enforcement:Z-1461-2023
Official wording
Reason: The product is brittle and potentially crumbling upon handling or when being removed from its package.
Code information: a) 5311-01240-010, Lot Number 19012112, exp. 12/31/2023; b) 5311-01240-012, Lot Number 19012112, exp. 12/31/2023
Distribution pattern: Worldwide distribution - US Nationwide and the countries of China, Germany, Sweden, Norway, Netherlands, Greece, Switzerland, France
Derived failure modes
-
Unknown
The product is brittle and potentially crumbling upon handling or when being removed from its package.