Medical device recalls: November 2020
The FDA posted 10 medical device recall records in November 2020, from 9 recall events by 9 companies. 2 are Class I, the most serious category.
Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.
Companies with the most recall events
- Advanced Bionics, LLC · 1 event, 2 records
- Boston Scientific Corporation · 1 event, 1 record
- Cook Inc. · 1 event, 1 record, 1 Class I
- Flexicare Medical Ltd. · 1 event, 1 record, 1 Class I
- Janus Trade Group · 1 event, 1 record
- Mako Surgical Corporation · 1 event, 1 record
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) · 1 event, 1 record
- Siemens Medical Solutions USA, Inc · 1 event, 1 record
FDA root cause
- Under Investigation by firm · 3
- Process control · 2
- Software design · 1
- Nonconforming Material/Component · 1
- No Marketing Application · 1
- Device Design · 1
- Component design/selection · 1
Class I recalls (2)
The most serious: a reasonable probability that using the device will cause serious health problems or death.
- Z-0497-2021 · Flexicare Medical Ltd. · posted Nov 26, 2020 · Terminated
When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient.
- Z-0399-2021 · Cook Inc. · posted Nov 3, 2020 · Terminated
Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide.
Class II recalls (6)
The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
- Z-0509-2021 · Janus Trade Group · posted Nov 30, 2020 · Terminated
Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG.
- Z-0472-2021 · Mako Surgical Corporation · posted Nov 19, 2020 · Completed
Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO and to execute bone preparation during…
- Z-0427-2021 · Boston Scientific Corporation · posted Nov 6, 2020 · Open, Classified
The recalling firm has observed an increase in complaints of problems encountered during the initial activation of the device in which the patient and/or the physician is unable or has difficulty activating the pump in order to achieve cylinder inflation.
- Z-0431-2021 · Stryker Instruments Div. of Stryker Corporation · posted Nov 6, 2020 · Terminated
Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.
- Z-0400-2021 · Siemens Medical Solutions USA, Inc · posted Nov 4, 2020 · Terminated
There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Pheno systems with software version VE20B. In rare cases, when the DSA acquisition has been started while the C-Arm or table is moving, there may be a shift…
- Z-0322-2021 · RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) · posted Nov 2, 2020 · Open, Classified
System does not include a drill guide.
Class III recalls (2)
Using the device is not likely to cause health problems, but it violates FDA rules.
- Z-0486-2021 · Advanced Bionics, LLC · posted Nov 25, 2020 · Terminated
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
- Z-0487-2021 · Advanced Bionics, LLC · posted Nov 25, 2020 · Terminated
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.