# P840062: Collacote (TM)

- Pathway: PMA
- Applicant: Integra Lifesciences Corp.
- Decided: Nov 8, 1985 after 350 days
- Product code: LPG (Material, Dressing, Surgical, Polylactic Acid)
- Device class: 3
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Mar 28, 2013 · Class II · Z-1296-2013: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Mar 28, 2013 · Class II · Z-1297-2013: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Mar 28, 2013 · Class II · Z-1291-2013: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Mar 28, 2013 · Class II · Z-1292-2013: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Mar 28, 2013 · Class II · Z-1294-2013: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Mar 28, 2013 · Class II · Z-1293-2013: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Mar 28, 2013 · Class II · Z-1295-2013: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Source page: https://510kreport.com/device/P840062
Methodology: https://510kreport.com/methodology