SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
FDA device recall Z-0026-2011 · posted 2010-10-08 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 23,205 Units for ALL PRODUCTS IN THIS RECALL
- Distribution
- 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.
- Date initiated
- 2009-01-01
- Date posted
- 2010-10-08
- Date terminated
- 2011-01-05
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPEEDLINK TRANSVERSE CONNECTOR (K002082) | Spinal Concepts, Inc. | 2000-10-06 |