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, or directly on bone. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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, or directly on bone.
Brand
Stryker Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
Lot code: U09984 VariaAx Elbow System Instrument Set - kitted, material transaction lots # U23151, U24021, U25906 and U29985 all contain one piece of the affected recalled catalog number.
Products Sold
Lot code: U09984 VariaAx Elbow System Instrument Set - kitted, material transaction lots # U23151, U24021, U25906 and U29985 all contain one piece of the affected recalled catalog number.
Stryker Howmedica Osteonics Corp. is recalling Depth Gauge; Catalog Number: 703707; Stryker Trauma AG, CH 2545 Selzach; Distributed in USA by Howme due to The Depth Measuring Gauges have 5 scale marking instead of the required 4 scale markings.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Depth Measuring Gauges have 5 scale marking instead of the required 4 scale markings.
Recommended Action
Per FDA guidance
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 attached Product Accountability Form and a copy should be faxed to 201-831-6069 within 5 days of receipt of the notice. Follow the instructions for shipping the affected product back to the firm. Questions should be directed to 201-972-2100.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026