Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for pedicle screw system.
This recall has been terminated (originally issued December 22, 2009).
- Company
- Zimmer Inc.
- Recall Initiated
- August 20, 2009
- Posted
- December 22, 2009
- Terminated
- April 13, 2011
- Recall Number
- Z-0554-2010
- Quantity
- 215
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The tip of the instrument may fracture during use.
Distribution
Nationwide, Belgium and New Zealand.
Lot / Code Info
Lots 47PN, 47PP, 49HK, 49HL and 57WL.
Root Cause
Device Design
Action Taken
Zimmer sent a letter dated 8/17/09 to distributors and consignees on or about 8/20/09. Users were notified of the potential problem via the letter and advised that the instruments will be removed and replaced when a new version of the instrument becomes available (around 10/09).
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