Cuff, Nerve
Neurology · 21 CFR 882.5275
Recent MDR events
165 adverse event reports on file
- AXOGUARD HA+ NERVE PROTECTORJun 30, 2026InjuryAxogen Corporation3017860045-2026-00010
- AXOGUARD HA+ NERVE PROTECTORJun 30, 2026InjuryAxogen Corporation3017860045-2026-00011
- AXOGUARD HA+ NERVE PROTECTORJun 19, 2026InjuryAxogen Corporation3017860045-2026-00008
- AXOGUARD HA+ NERVE PROTECTORMay 29, 2026InjuryAxogen Corporation3017860045-2026-00007
- AXOGUARD HA+ NERVE PROTECTORMay 8, 2026InjuryAxogen Corporation3017860045-2026-00006
- AXOGUARD HA+ NERVE PROTECTORApr 24, 2026InjuryAxogen Corporation3017860045-2026-00005
- AXOGUARD HA+ NERVE PROTECTORApr 5, 2026InjuryAxogen Corporation3017860045-2026-00004
- AXOGUARD HA+ NERVE PROTECTORApr 3, 2026InjuryAxogen Corporation3017860045-2026-00003
- AXOGUARD HA+ NERVE PROTECTORMar 5, 2026InjuryAxogen Corporation3017860045-2026-00002
- AXOGUARD HA+ NERVE PROTECTORFeb 15, 2026InjuryAxogen Corporation3017860045-2026-00001
Event type breakdown
Recalls
4 recall events for this product code
- Baxter Healthcare CorporationOpen, ClassifiedApr 25, 2023
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
The product is brittle and potentially crumbling upon handling or when being removed from its package.
Z-1461-2023 · View FDA record ↗ - Integra LifeSciences CorporationTerminatedMay 10, 2013
NeuraWrap Nerve Protector
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
Z-1286-2013 · View FDA record ↗ - Integra LifeSciences CorporationTerminatedMay 10, 2013
NeuraGen Nerve Guide
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
Z-1287-2013 · View FDA record ↗ - Integra LifeSciences Corp.TerminatedUnknown
NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve disconti
Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.
Z-1470-2020 · View FDA record ↗
Registered firms
80 firms currently registered for this product code
Integra Lifesciences Corporation
Princeton, NJ, US
Steritech, Inc.
SALINAS, PR, US
Synergy Health Ast, Llc
SAN DIEGO, CA, US
Collagen Matrix, Inc.
Oakland, NJ, US
Mochida Pharmaceutical Co., Ltd
Shinjuku-ku Tokyo, JP
Isomedix Operations Inc.
CHESTER, NY, US
Cook Biotech, Inc.
West Lafayette, IN, US
Axogen Corporation - Tampa Heights
Tampa, FL, US
Ha2 Medizintechnik Gmbh
Halberstadt Saxony-Anhalt, DE
Allosource
Centennial, CO, US
Viant Medical, Inc.
Grand Rapids, MI, US
Checkpoint Surgical Inc.
Brecksville, OH, US
Cook Incorporated
ELLETTSVILLE, IN, US
Steritech
Dandenong Victoria, AU
Biocircuit Technologies
Atlanta, GA, US
Sterigenics Belgium Petit Rechain S.a.
Verviers Liege, BE
Alafair Biosciences, Inc.
Austin, TX, US
Renerve Ltd
Melbourne Victoria, AU
Checkpoint Surgical Inc.
Independence, OH, US
510(k) clearances
40 clearances for this product code
- KLISBio S.r.l.Apr 9, 2026
K260245 · SILKBridge
- Auxilium Biotechnologies, Inc.Jan 17, 2026
K253363 · NeuroSpan Bridge
- Alafair BiosciencesJul 22, 2025
K251505 · VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)
- Alafair BiosciencesJul 17, 2025
K251175 · VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)
- Orthocell, Ltd.Apr 2, 2025
K243889 · Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)
- Biocircuit Technologies, Inc.Apr 2, 2025
K242113 · Nerve Wrap (07-DW-001-TAB)
- Mochida Pharmaceutical Co., Ltd.Jun 21, 2024
K233322 · Mochida Nerve Cuff
- Biocircuit Technologies, Inc.Feb 12, 2024
K233533 · NerveTape