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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm June 15, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on June 17, 2005
Recall Number Z-1083-04
Recall Event ID 29386
Product Classification Component, External, Limb, Ankle/Foot - Product Code ISH
Product VSP Shock Module (as part of a prosthetic foot).
Code Information RFL0001, RFL00008, RFL50006, RFX00001, RFX00002, RFX00012.
Recalling Firm/
Manufacturer		 Ossur North America Inc
27412 Aliso Viejo Pkwy
Aliso Viejo CA 92656-3371
For Additional Information Contact Margret Ormslev
354-515-1300
Manufacturer Reason
for Recall		 Flawed shock module might cause breakage causing patient to fall.
FDA Determined
Cause 2		 Other
Action Firm will be contacting customers and patients to replace the defective components. Contact will be made by mail and by phone.
Quantity in Commerce 37
Distribution Nationwide.
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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