Synthes, Inc.
Synthes, Inc. holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2013, with 43 FDA device recalls on record.
Top product codes for Synthes, Inc.
FDA recalls by Synthes, Inc.
10 most recent of 43- Z-2698-2020 — MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.
- Z-0880-2020 — 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
- Z-0879-2020 — 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
- Z-0882-2020 — 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
- Z-0883-2020 — 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
- Z-0881-2020 — 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
- Z-1514-2018 — Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
- Z-1511-2018 — Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mounting for minimally invasive spine surgery. The Flex Arm is designed to hold Synthes Minimally Invasive Retractors, which are connected to the Flex Arm by adapters.
- Z-0669-2018 — LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
- Z-2051-2015 — TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Synthes, Inc.
- K131792 — SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY
- K122647 — SYNTHES PATIENT SPECIFIC PLATE
- K113567 — SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
- K121502 — SYNTHES CURVILINEAR DISTRACTION SYSTEM
- K121574 — SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
- K113251 — SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES
- K111323 — SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
- K112689 — SYNTHES STERNAL FIXATION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.