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U.S. Department of Health and Human Services

Class 2 Device Recall Oxford Gap Gauge

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 Class 2 Device Recall Oxford Gap Gaugesee related information
Date Initiated by FirmJuly 27, 2012
Date PostedAugust 17, 2012
Recall Status1 Terminated 3 on February 15, 2013
Recall NumberZ-2224-2012
Recall Event ID 62745
Product Classification Device, prosthesis alignment - Product Code IQO
ProductOxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component.
Code Information Catalog Number: 32-422801 and Lot Number Identification: ZB111101, ZBll1201, ZB120101, ZB120501, ZB111102, and ZB120201.
FEI Number 3002806535
Recalling Firm/
Manufacturer		 Biomet U.K., Ltd.
Waterton Industrial Estate
Bridgend, South Wales United Kingdom
Manufacturer Reason
for Recall		A drafting error during an unrelated design change has led to 4 misleading dimensions on the drawing. The CAD model remained the same thickness but the problem dimensions were accidentally struck from an incorrect point result in an increase of 1.0mm in the value of each dimension
FDA Determined
Cause 2		Device Design
ActionBiomet sent a "FIELD SAFETY CORRECTIVE ACTION" letter dated July 24, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Response Form was attached for customers to complete and return. Contact the firm for questions regarding this notice.
Quantity in Commerce119 units
DistributionWorldwide Distribution-USA-including the states of IN, SD, and TX and the countries of Austria, China, Japan, Netherlands, Sweden, Turkey, and UK.
Total Product Life CycleTPLC 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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