Recall Z-0880-2008 ยท GZT Retractor, Self-Retaining, For Neurosurgery
Abbott Spine
Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of the following consignment surgical kits: Harmony 2700-0001-PL, Harmony 2700-0009-PL, Harmony 2900-0001-PL, Harmony 2900-0002-PL, Cadence 1500-0002-PL and Cadence 1500-0008-PL; Distributed by Abbott Spine, Austin, TX 78727.
| Date | Feb 13, 2008 (initiated Dec 19, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050706 | HARMONY PORT SYSTEM, MODEL 1907 SERIES Spinal Concepts, Inc., Apr 15, 2005 |