TPLC - Total Product Life Cycle

• Device: restraint, protective
• Regulation Description: Protective restraint.
• Product Code: FMQ
• Regulation Number: 880.6760
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
ABCO DEALERS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALIMED, INC.
	SUBSTANTIALLY EQUIVALENT	3
BIOMET
	SUBSTANTIALLY EQUIVALENT	1
CHILDREN'S HEALTH FIRST, INC.
	SUBSTANTIALLY EQUIVALENT	1
CONTOUR FABRICATORS, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY INTL., LTD.
	SUBSTANTIALLY EQUIVALENT	2
DEROYAL
	SUBSTANTIALLY EQUIVALENT	15
EM ADAMS
	SUBSTANTIALLY EQUIVALENT	2
HOLLISTER, INC.
	SUBSTANTIALLY EQUIVALENT	4
J. T. POSEY CO.
	SUBSTANTIALLY EQUIVALENT	9
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE
	SUBSTANTIALLY EQUIVALENT	7
SKIL CARE
	SUBSTANTIALLY EQUIVALENT	12
TRISTATE
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Other (for use when an appropriate device code cannot be identified)	39
Locking mechanism failure	20
Unknown (for use when the device problem is not known)	17
Tears, rips, holes in device, device material	15
No code available	12
Component(s), broken	8
Break	6
Close, difficult to	6
Use of Device Issue	5
Hole in material	3
Detachment of device component	2
Entrapment of device or device component	2
Unexpected therapeutic results	2
Loose	1
Misapplication	1
Out-of-box failure	1
Total Device Problems	140

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	1	2	0	0	0	1
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	J T Posey Company	II	Apr-09-2013
2	J T Posey Company	II	Sep-22-2009
3	J T Posey Company	II	Feb-03-2009
4	J T Posey Company	II	Dec-02-2008