Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G
This recall has been terminated (originally issued December 28, 2005).
- Recall Initiated
- October 21, 2005
- Posted
- December 28, 2005
- Terminated
- April 16, 2008
- Recall Number
- Z-0328-06
- Quantity
- 141 units.
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Detachable T-handles used in hip instrument sets and shoulder instrument sets may fail during shipment or upon initial use because they were incorrectly assembled.
Distribution
Device distributed nationwide to direct accounts in AZ, CA, FL, GA, IA, IL, KS, LA, MA, MD, MI, MO, MT, NM, NH, NJ, OK, OH, PA, SC, SD, TX, UT, VA, and WA. Foreign distribution to Saudi Arabia, Japan and Germany.
Lot / Code Info
Revision G (instrument not tracked by lot number).
Root Cause
Other
Action Taken
The firm initiated the recall on 10/21/05 via letter to all consignees.