Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1611-2011

MMP 200 Articulating Booms, Catalog Number 0682-000-604SX, Product Number 0682-001-060C. Used for operating...

STRYKER Communications, Inc. / initiated 2011-01-28 / Terminated / root cause: manufacturing process

Stryker Communications Corp began a recall of MMP 200 Articulating Booms, Catalog Number 0682-000-604SX, Product Number 0682-001-060C. Used for operating room equipment on . The reason FDA records is "Utilization of incorrect screws resulted in inadequate thread engagement reducing the load bearing capability of the product". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1611-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
STRYKER Communications, Inc.
Product
MMP 200 Articulating Booms, Catalog Number 0682-000-604SX, Product Number 0682-001-060C. Used for operating room equipment.
Reason for recall
Utilization of incorrect screws resulted in inadequate thread engagement reducing the load bearing capability of the product.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
Stryker notified consignees verbally on January 28, 2011 and by letter dated February 11, 2011.
Quantity in commerce
2
Distribution
MA, CO
Product codes and lots
Serial numbers 02074510100008 and 0207451010000