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U.S. Department of Health and Human Services

Class 2 Device Recall Genesis Uni Articular Inserts

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 Class 2 Device Recall Genesis Uni Articular Insertssee related information
Date Initiated by FirmJune 21, 2004
Date PostedDecember 14, 2004
Recall Status1 Terminated 3 on February 15, 2006
Recall NumberZ-0304-05
Recall Event ID 29816
510(K)NumberK912735 
Product Classification Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer - Product Code HSX
ProductGenesis Uni Articular Inserts
Code Information Genesis Uni Articular Inserts 71248108, 71248109, 71248110, 71248111, 71248112, 71248208, 71248209, 71248210, 71248211, 71248212, 71248308, 71248309, 71248310, 71248311, 71248312, 71248228, 71248229, 71248230, 71248231, 71248232, 71248235, 71248328, 71248329, 71248330, 71248331, 71248332, 71248335, 71248338, 71248339, 71248340, 71248341, 71248342, 71248345 Sold internationally: 71975865, 71975866, 71975867, 71975870, 71975871, 71975872, 71975873 
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information ContactR. Gordon Howe
901-399-5563
Manufacturer Reason
for Recall		The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.
FDA Determined
Cause 2		Other
ActionRecall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email) on 06/21/2004 to request the return of any in stock product.
Quantity in Commerce11,339 units were distributed
DistributionNationwide, 43 consignees, 17 countries: Germany, France, Australia, Italy, Switzerland, United Arab Emirates, Belgium, Japan, United Kingdom, Singapore, Spain, Taiwan. Sweden, Canada Venezuela, South Africa, and Israel.
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 = HSX
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