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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJune 15, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on June 17, 2005
Recall NumberZ-1083-04
Recall Event ID 29386
Product Classification Component, External, Limb, Ankle/Foot - Product Code ISH
ProductVSP Shock Module (as part of a prosthetic foot).
Code Information RFL0001, RFL00008, RFL50006, RFX00001, RFX00002, RFX00012.
FEI Number 1000519909
Recalling Firm/
Manufacturer		 Ossur North America Inc
27412 Aliso Viejo Pkwy
Aliso Viejo CA 92656-3371
For Additional Information ContactMargret Ormslev
354-515-1300
Manufacturer Reason
for Recall		Flawed shock module might cause breakage causing patient to fall.
FDA Determined
Cause 2		Other
ActionFirm will be contacting customers and patients to replace the defective components. Contact will be made by mail and by phone.
Quantity in Commerce37
DistributionNationwide.
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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