Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of the following consignment surg
FDA device recall Z-0880-2008 · posted 2008-02-13 · Terminated
Recall details
- Recalling firm
- Abbott Spine
- Reason for recall
- Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearings during use.
- Action taken
- All medical suppliers with consigned inventory from affected lots were contacted via phone beginning 12/19/07. Consignees notified of potential issue and were asked to inspect their inventory and contact Abbott Spine for return and replacement of the affected handles.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GZT
- Quantity affected
- 230 handles.
- Distribution
- Worldwide:Medical suppliers in the following states: AR, AZ, CA, CT, FL, IL, LA, MD, MI, MO, MN, NC, NJ, NM, NV, OH, OK, OR, PA, TX, VA and WI. and country of Spain.
- Date initiated
- 2007-12-19
- Date posted
- 2008-02-13
- Date terminated
- 2010-10-04
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HARMONY PORT SYSTEM, MODEL 1907 SERIES (K050706) | Spinal Concepts, Inc. | 2005-04-15 |