SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
FDA Recall Z-0028-2011 · Posted 2010-10-08
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeKWP
Date Initiated2009-01-01
Date Terminated2011-01-05
Product Quantity23,205 Units for ALL PRODUCTS IN THIS RECALL
Reason for Recall
The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. There were also complaints that the cam may dislodge during tightening. The firm added additional instructions for use to reduce the probability of these two types of events.
Firm Action
The firm provided a revised surgical technique document to the Zimmer spine sales force in January, 2009. The firm will provide an Urgent Medical Device Correction notification to speedlink users through the sales force.
Root Cause
Other
Distribution Pattern
The devices are contained in implant cases stocked by Zimmer spine and made available to the Zimmer sales force for surgeries. They are not in general distribution.
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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