Arthrex, Inc.
FDA adverse event reports naming Arthrex, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ARTHREX, INC..
- Total reports
- 1,173
- Deaths
- 0
- Injuries
- 1,172
- Malfunctions
- 1
Reports per year
Source: FDA adverse event reports by year received, 2013–2018. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Instrument, Manual, Surgical, General UseMDM243
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH157
- Fastener, Fixation, Biodegradable, Soft TissueMAI145
- Suture, Nonabsorbable, Synthetic, PolyethyleneGAT140
- Screw, Fixation, BoneHWC114
- Plate, Fixation, BoneHRS78
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS63
- Orthopedic Manual Surgical InstrumentLXH48
- ArthroscopeHRX42
- Washer, Bolt NutHTN37
Recent recalls
- 2022-12-08Open, ClassifiedUnder Investigation by firm
Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.
The devices may be packaged with the wrong reamer size.
- TerminatedProcess control
iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from painful osteoarthritis or posttraumatic arthritis. 2. Correction of functional deformity. 3. Revision of previous unsuccessful uni-compartmental knee replacement or other procedure. 4. As an alternative to tibial osteotomy in patients with uni-compartmental osteoarthritis.
Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 UFRA, size 1 printed on the patient label inside the box.
- Open, ClassifiedUnder Investigation by firm
Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.
The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress.
- Open, ClassifiedSoftware change control
3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and 1.6mm x 12 K-Wire.
There is potential to break during use.
- Open, ClassifiedProcess control
Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist
Potentially lead to anchor breakage during insertion,
- TerminatedProcess control
Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
There is a potential for blockage of the Hub Attachment Tube.
- TerminatedNonconforming Material/Component
K-Wire, 1.35 mm x 170 mm
Products do not meet length and diameter specifications.
- TerminatedNonconforming Material/Component
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).
Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.
- TerminatedUnknown/Undetermined by firm
Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures.
Devices may generate excessive heat during use.
- TerminatedUnder Investigation by firm
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
Monitor Arthrex, Inc. automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.