Medical Device Recall: Z-0040-05

FDA Recalls dataset · Firm: Zimmer Spine, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2004-08-24 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0040-05.

Recall Res Number
Z-0040-05
Recalling Firm / Manufacturer
Zimmer Spine, Inc.
FEI Number
1000115775
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2004-08-24
Date Posted
2004-10-23
Date Terminated
2005-11-03
Product Code
KWQ
Event Number
29908
Product Quantity
82 sets
Product Description ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Reason for Recall To date, there has been one complaint reported. During a Trinica surgical case, the surgeon was provided a standard disposable, Trinica Drill Bit (part number 07.00166.001) for use with the Trinica All Through One Drill Guide Instrumentation, instead of the ALL Through One Drill Bit. This enabled the physician to drill a few millimeters further than expected.
Action Details The product distributed to accounts will be returned to Zimmer Spine. Product will be quarantined pending investigation and determination of appropriate corrective action.
Distribution Pattern Product was distributed nationwide throughout the United States. Product was not distributed outside of the United States.
Code Information / Serial Numbers Serial Numbers: ATO-001 through ATO-0082

Related Establishments / Registrations

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