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.
This recall has been terminated (originally issued February 13, 2008).
- Company
- Abbott Spine
- Recall Initiated
- December 19, 2007
- Posted
- February 13, 2008
- Terminated
- October 4, 2010
- Recall Number
- Z-0880-2008
- Quantity
- 230 handles.
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Lot Numbers: 13ZD, 14KC, 21NJ, 29XC, 36TP, 38AE, 39NN, 43CC, 43SW, 45KK, and 46WK.
Root Cause
Device Design
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.