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‘‘The Silver Sheet’’
Elsevier Business Intelligence
Manufacturer
Product
Class Reason
Smith & Nephew
Peri-Loc
II
Inner packaging of the sterile product was not sealed. (Z-2314-2010)
Smith & Nephew
Cerclage Wire
II
Plastic trays that encase these products have burrs on the
hinged packaging, which can puncture the single-barrier sterile
pouch, compromising sterility. (Z-2197/2199-2010)
Smith & Nephew
Aimer Endofemoral
II
Tip may separate due to failure of the soldered joint.
(Z‑0040/0048-2011)
Smith & Nephew
R3 22 MM I.D.
II
The femoral head may pop out of the liner intraoperatively.
(Z‑0079/0086-2011)
Smith & Nephew
Trigen Sureshot Distal Targeting
System
II
Software has been found to provide erroneous targeting.
(Z‑0411-2011)
Smith & Nephew
Fast Fix 360 Needle Delivery
System
II
System may not allow the T-2 anchor to advance for implantation. (Z-0419/0421-2011)
Smiths Medical
Medfusion Syringe Infusion Pumps II
Pumps with obsolete software may continue to run past the set
volume limit. This can result in over-delivery if the syringe is
overfilled. (Z-2121-2010)
Smiths Medical
AC Power Cords
II
Potential for the power cord’s prongs, made by Electri-Cord Manufacturing, to crack and fail at/or inside the plug. (Z-1082-2010)
Smiths Medical
CADD-Legacy 1 Ambulatory Infusion Pump
II
Pump was shipped without documentation that required accuracy testing had been performed during the manufacturing
process. If the pump did not go through accuracy testing and
does not meet accuracy specifications, there is a potential for
over- or under-delivery. (Z-1235-2010)
Smiths Medical
Medfusion Syringe Infusion Pumps II
There has been an increased trend in reports of “Motor Not
Running” (MNR) and “Motor Rate Error” (MRE) alarm-message
events. This is likely to cause an interruption or delay in therapy
for the patient. (Z-0650/0651-2010)
Smiths Medical
Power Cords
II
According to FDA, two medical device manufactures have
reported incidents of sparking, charring and fires from power
cords made by Electri-Cord Manufacturing. (Z-0918/0920-2010)
Solafeet
Foot Portable Tanners
II
Product failed to have a label that contained a recommended
exposure schedule, and the operator’s manual provided inadequate instructions for use. (Z-0608-2010)
SonaMed
Clarity System II
II
There is insufficient evidence to support any claims for safety
and efficacy. (Z-2165-2010)
Sonosite
Tee Transducer
II
The transducer, when connected to a Sonosite M-Turbo ultrasound
system, may exhibit erratic operation of the “Scanplane Orientation Indicator” on the system display. The indicator may move
erratically and not accurately represent the orientation of the Tee
transducer array. (Z-2191-2010)
Sonosite
PowerPark System
II
System has the potential for loss of power at the corresponding
wall outlet and/or circuit due to poor alignment. (Z-2116-2010)
Sonosite
ARM Software
III
Software on the NanoMaxx ultrasound system results in errors
when the “Print” command is selected. As a result, the displayed MI or TI values may be incorrect. (Z-0478-2011)
Sorin Group
Paradym CRT-D Devices
II
Devices have a software anomaly that causes the device to lose
the ability to sense/pace and deliver further therapy. (Z-2579-2010)
50 | FEBRUARY 2011
© 2011 F-D-C Reports, Inc., an Elsevier company. All rights reserved.