Recalls / —
—#88648
Product
SpeedLink 6.0 Transverse Connector Medium 43-51mm, non-sterile, 1304-60M
- FDA product code
- KWP — Appliance, Fixation, Spinal Interlaminal
- Device class
- Class 2
- Medical specialty
- Orthopedic
- Affected lot / code info
- 14MM, 15EE, 27LL, 35HR, 41HC, 45XA, 7EA, 8BQ and 9FZ.
Why it was recalled
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.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Zimmer Inc.
- Address
- 345 E Main St, Warsaw, Indiana 46580-2746
Distribution
- 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.
Timeline
- Recall initiated
- 2009-01-01
- Posted by FDA
- 2010-10-08
- Terminated
- 2011-01-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #88648. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.