Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1014-04

Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica...

Zimmer Spine, Inc. / initiated 2004-05-21 / Terminated

Zimmer Spine, Inc. began a recall of Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets... on . The reason FDA records is "The recalled bone taps could break inside the vertebral body during the tapping process". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1014-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Zimmer Spine, Inc.
Product
Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets.
Product code
HWX Tap, Bone
Reason for recall
The recalled bone taps could break inside the vertebral body during the tapping process.
FDA root cause
Other
Action
Recall letters, dated May 25, 2004, request that the consignees locate and return the recalled devices.
Quantity in commerce
55 units
Distribution
The product was shipped to Hawaii, New York, South Carolina, and South Dakota in the United States.
Product codes and lots
Lot P020077.