West Chester, PA, United States
Synthes, Inc. recalls
6 recalls recorded since 2018, most recently on 18 June 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)0
Terminated or completed6
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 18 June 2020
- Terminated
- 13 April 2021
- Reason
- One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw.
- Distribution
- International distribution including in the countries of Australia, Belgium, Chile, France, Slovakia, South Korea.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 se
Terminated Class II Medical devices
- Recall started
- 16 December 2019
- Terminated
- 8 June 2020
- Reason
- There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.
- Distribution
- US Nationwide distribution in the states of AL and ID.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0882-2020, Z-0879-2020, Z-0883-2020, Z-0881-2020, Z-0880-2020
- 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.
- 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.
- 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.
- 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.
- 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.
Terminated Class II Medical devices
- Recall started
- 19 March 2018
- Terminated
- 11 April 2019
- Reason
- There is a potential for the connection screw of the stem extractor to break.
- Distribution
- Worldwide Distribution: US (nationwide) and to countries of: Canada and Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1514-2018
- Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
Terminated Class II Medical devices
- Recall started
- 5 March 2018
- Terminated
- 16 October 2019
- Reason
- Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Switzerland and Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 hol
Terminated Class II Medical devices
- Recall started
- 10 August 2017
- Terminated
- 10 September 2018
- Reason
- The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.
- Distribution
- Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0618-2018, Z-0617-2018
- Norian Drillable Inject
- Norian Drillable Inject
Terminated Class II Medical devices
- Recall started
- 7 August 2017
- Terminated
- 25 July 2018
- Reason
- May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening.
- Distribution
- Distribution to US, Canada, and Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.