Recall Z-0796-2010 ยท HTJ Gauge, Depth
Stryker Howmedica Osteonics Corp.
Depth Gauge; Catalog Number: 703707; Stryker Trauma AG, CH 2545 Selzach; Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. This product is sold separately or as part of Kit # 990256. The depth gauge is an instrument in the VariAx Elbow System. Depth gauges are tools used intra-operatively, to aid in correct screw selection. They can be used with a plate, o
| Date | Feb 19, 2010 (initiated Dec 22, 2009) |
| Status | Terminated |
| Reason | The Depth Measuring Gauges have 5 scale marking instead of the required 4 scale markings. |
| Root cause | Process control |
| Action | Urgent Product Recall letters, dated December 22, 2009, were sent to all Stryker Branches/Agencies. Letters were also sent to hospitals and surgeons that use the VariaAx Elbow System were also notified. All letters were sent by Federal Express. The letters identified the affected product, stated the issue, and the hazards involved. It also asked customers to examine their inventory and hospital locations to identify affected products. All affected products are to be retrieved and returned to their branch or agency warehouse for reconciliation. All products should be reconciled on the att |
| Quantity | 49 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.