FDA Recall
Terminated
Stryker Osteosynthesis Reduction Spoon; 1 single unit to a package; non-sterile; Stryker Trauma GmbH, 2432 Schonkirchen, Germany. Distributed in the US by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 007430 Reduction spoons are sold separately or as part of a kit. The Universal Rod with Reduction Spoon may be used as a fracture reduction tool to facilitate Guide Wire insertion.
Recall: Z-0191-2009
·
Initiated August 14, 2008
Recall
- Recall Number
- Z-0191-2009
- Event Number
- 49497
- Firm
- Stryker Howmedica Osteonics Corp.
- FEI Number
- 3003070421
- Product Code
- LXH
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- August 14, 2008
- Posted
- October 28, 2008
- Terminated
- May 29, 2012
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430
Description
Stryker Osteosynthesis Reduction Spoon; 1 single unit to a package; non-sterile; Stryker Trauma GmbH, 2432 Schonkirchen, Germany. Distributed in the US by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 007430 Reduction spoons are sold separately or as part of a kit. The Universal Rod with Reduction Spoon may be used as a fracture reduction tool to facilitate Guide Wire insertion.
Reason
Stryker has become aware of the potential for breakage of the Reduction Spoon designed prior to 2003.
Action
Recall notification letters were sent on August 14, 2008 to all branches and hospitals via Federal Express. Questions are to be directed to 201-831-5718 or a Trauma team member listed in the letter.
Distribution
Nationwide
Quantity
1070 units