Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

SpeedLink 6.0 Transverse Connector Medium 43-51mm, non-sterile, 1304-60M

FDA Recall Z-0031-2011 · Posted 2010-10-08

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑