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.
FDA Recall Z-1014-04 · Posted 2005-02-24
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Recalling FirmZimmer Spine, Inc.
Recall StatusTerminated
Product CodeHWX
Date Initiated2004-05-21
Date Terminated2005-11-03
Product Quantity55 units
Reason for Recall
The recalled bone taps could break inside the vertebral body during the tapping process.
Firm Action
Recall letters, dated May 25, 2004, request that the consignees locate and return the recalled devices.
Root Cause
Other
Distribution Pattern
The product was shipped to Hawaii, New York, South Carolina, and South Dakota in the United States.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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