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U.S. Department of Health and Human Services

Class 2 Device Recall Depth Gauge

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  Class 2 Device Recall Depth Gauge see related information
Date Initiated by Firm December 22, 2009
Date Posted February 19, 2010
Recall Status1 Terminated 3 on March 16, 2010
Recall Number Z-0796-2010
Recall Event ID 54198
Product Classification Depth Gauge - Product Code HTJ
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Colleen O'Meara
201-831-5980
Manufacturer Reason
for Recall		 The Depth Measuring Gauges have 5 scale marking instead of the required 4 scale markings.
FDA Determined
Cause 2		 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 in Commerce 49
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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