Zimmer Spine Cyclone anterior cervical plate, 2 Level, 44MM (Ti-6Al-4V); REF 600-02-144.
FDA device recall Z-1732-2008 · posted 2008-09-01 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The screw locking cap may fracture when the surgeon rotates it into the locked position.
- Action taken
- Consignees were notified via voicemail on 3/26/08 and a letter was sent to all distributors on 3/27/08 informing them that the plate should no longer be used and that all lots are being recalled. A letter dated 6/18/08 was issued to implant physicians recommending patient monitoring. Contact Zimmer Spine at 1-952-857-5636 for assistance.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWQ
- Distribution
- Arizona, California, Florida, Georgia, Louisiana, Michigan, Minnesota, Montana, New Hampshire, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin.
- Date initiated
- 2008-03-26
- Date posted
- 2008-09-01
- Date terminated
- 2009-11-12
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM (K040397) | Encore Medical L.P. | 2004-05-06 |
| CYCLONE ANTERIOR CERVICAL PLATE SYSTEM (K031214) | Encore Medical L.P. | 2003-09-23 |