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MID CENTRAL MEDICAL CORP. · Model MCM154 · UDI-DI 10810030860294

FWZ

510(k) clearances

1,818

Adverse events (2 deaths)

Recalls

159

Facilities

Description

Stand Alone leg Prep. This is the new stand alone leg prep from Mid Central Medical. There are many types of leg preppers in the industry that mount directly to the surgical table rail and support patients lower limbs. However, these all attach to the table and are limited in positioning. The stand alone leg prep can be used next to the table just as most others are used but can also be placed independently away from the table for various types of cases. Another great use for this leg prep is when surgery is performed on a stretcher or gurney instead of an OR Table. There is no rail on the stretcher to accommodate the standard leg prep but the stand alone leg prep is a great fit! Can be used in infinite positions for arms and legs, whatever the procedure. With rotating support, pretty much any position can be achieved.

Recalls

Date	Firm	Reason
2024-02-14	Baxter Healthcare Corporation	Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the
2017-03-28	Mizuho OSI	Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construction of their mounting sleeves that may allow the patient to contact the underlying
2015-08-17	Maquet Cardiovascular Us Sales, Llc	Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part Number 1007.24F0) fo
2015-08-17	Maquet Cardiovascular Us Sales, Llc	Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part Number 1007.24F0) fo
2014-12-19	Integra LifeSciences Corporation	Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use.
2014-10-08	Customed, Inc	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage condit
2014-10-08	Customed, Inc	Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncont
2014-10-08	Customed, Inc	Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncont
2014-10-08	Customed, Inc	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage condit
2014-10-08	Customed, Inc	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage condit

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.