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U.S. Department of Health and Human Services

Class 2 Device Recall Depuy DELTA Xtend

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 Class 2 Device Recall Depuy DELTA Xtendsee related information
Date Initiated by FirmJuly 10, 2008
Date PostedJanuary 15, 2009
Recall Status1 Terminated 3 on October 28, 2009
Recall NumberZ-0538-2009
Recall Event ID 49112
510(K)NumberK062250 K081620 
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
ProductDepuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+9 STD, sterile, Depuy France; REF 130742209. The device is used as a shoulder implant.
Code Information All lots.
Recalling Firm/
Manufacturer
Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact
800-473-3789
Manufacturer Reason
for Recall
Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
FDA Determined
Cause 2
Device Design
ActionA letter, "Urgent Device Correction" dated July 8, 2008 was sent via certified mail to implanting surgeons advising them of the issues and guidance on how to mitigate the problem. A communication was also sent to all sales representatives and territory offices on July 15, 2008. For questions, please contact Depuy Orthopaedics, Inc. Customer Service at 1-800-473-3789.
Quantity in Commerce1,521 of all devices.
DistributionNationwide Distribution.
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.
510(K) Database510(K)s with Product Code = KWS
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