TPLC - Total Product Life Cycle

• Device: guide, surgical, instrument
• Regulation Description: Manual surgical instrument for general use.
• Product Code: FZX
• Regulation Number: 878.4800
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
ASPEN LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
BIOSEARCH MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
CIVCO
	SUBSTANTIALLY EQUIVALENT	1
MEADOX
	SUBSTANTIALLY EQUIVALENT	1
MEDCARE
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Fracture	12
Break	9
Insulation, detached	5
Use of Device Issue	3
Unknown (for use when the device problem is not known)	3
No Information	3
Difficult to remove	2
Failure to align	2
Unsealed device packaging	2
Material fragmentation	2
Mislabeled	1
Detachment of device component	1
Connection error	1
Crack	1
Peeled	1
Fitting problem	1
Component missing	1
Residue after decontamination	1
Malfunction	1
Device, removal of (non-implant)	1
Malposition of device	1
Device markings issue	1
Incorrect device or component shipped	1
Manufacturing or shipping issue associated with device	1
Scratched material	1
No code available	1
Total Device Problems	59

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Oct-20-2011
2	Biomet, Inc.	II	Mar-28-2011
3	Biomet, Inc.	II	Nov-19-2009
4	Integra Life Sci.	II	Sep-14-2012