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U.S. Department of Health and Human Services

Class 2 Device Recall Ossur Total Knee

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 Class 2 Device Recall Ossur Total Kneesee related information
Date Initiated by FirmApril 02, 2007
Date PostedJuly 12, 2007
Recall Status1 Terminated 3 on May 28, 2008
Recall NumberZ-1076-2007
Recall Event ID 38115
Product Classification external knee prosthesis - Product Code ISY
ProductOssur Total Knee Model Number 2100, external knee prosthesis.
Code Information US affected Serial Numbers (1) New units: 9056, 9062, 9063, 9088, 9089, 9090, 9092, 9094, 9095, 9096, 9097, 9099, 9100, 9101, 9102, 9103, 9104, 9105, 9106, 9107, 9108, 9109, 9110, 9111, 9112, 9113, 9114, 9115, 9116, 9117, 9118, 9127, 9129, 9130, 9159, 9160, 9162, 9163, 9166 and 9169.   (2) Repaired units: 5138, 5141, 6624 and 9098. 
Recalling Firm/
Manufacturer		 Ossur
Grjothals 5
Reykjavik Ireland
For Additional Information ContactDick Smith
517-629-8890 Ext. 4104
Manufacturer Reason
for Recall		Some units of the Total Knee Model 2100 produced from August 1, 2006 through October 4, 2006 may contain a faulty linkage component.
FDA Determined
Cause 2		Other
ActionOn 4/2/07 a letter was mailed to all affected customers via certified mail, return receipt requested. All mailing will be followed by telephone calls from an Ossur Customer Service Representative. Customers were notified that Ossur will replace the affected knees with units carrying a two-year warranty from the date of replacement. Ossur will undertake a sub-recall by notifying the one affected distributor by letter on 4/2/07. Ossur will follow up with this distributor by telephone and request a list of consignees that the distributor sold the product to so that Ossur can directly contact each of those consignees. Upon receipt of this list, Ossur will then communicate the recall information directly to these consignees.
Quantity in Commerce44
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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