Recall Z-0191-2009 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
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.
| Date | Oct 28, 2008 (initiated Aug 14, 2008) |
| Status | Terminated |
| Reason | Stryker has become aware of the potential for breakage of the Reduction Spoon designed prior to 2003. |
| Root cause | Device Design |
| 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. |
| Quantity | 1070 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.