Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001.
FDA device recall Z-0370-2010 · posted 2009-11-19 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The spacer cutter may jam during surgery, preventing use of the instrument and causing surgical delay.
- Action taken
- Consignees were notified by letter dated 5/20/09 titled "Urgent Medical Device Correction" that instructed customers that they may continue to use the recalled product until adequate replacements become available, but that they should always ensure they have a backup spacer cutter (of a different model which does not have this issue) available in case this model should jam during use. Users were also advised to ensure the spacer cutter is properly lubricated and is sharp. For questions, please contact Zimmer Spine at 1-800-777-7505.
- Root cause
- Other
- Status
- Terminated
- Product code
- NQP
- Quantity affected
- 177
- Distribution
- Nationwide, Austria, Belgium, Canada, Italy, Netherlands, Singapore, Spain, Switzerland and United Kingdom.
- Date initiated
- 2009-05-28
- Date posted
- 2009-11-19
- Date terminated
- 2011-10-05
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DYNESYS TOP-LOADING SPINAL SYSTEM (K073347) | Zimmer Spine, Inc. | 2008-02-08 |