FDA Medical Device Recalls (openFDA)
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 number
- Z-0796-2010
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- 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.
- Status
- Terminated
- Initiated
- 2009-12-22
- Posted
- 2010-02-19
- Terminated
- 2010-03-16
- 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 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.
- Quantity
- 49
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTJ
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28