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U.S. Department of Health and Human Services

Class 2 Device Recall OSS Elliptical Proximal Femoral Trial 7 cm

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  Class 2 Device Recall OSS Elliptical Proximal Femoral Trial 7 cm see related information
Date Initiated by Firm May 19, 2009
Date Posted June 29, 2009
Recall Status1 Terminated 3 on October 08, 2010
Recall Number Z-1530-2009
Recall Event ID 51980
510(K)Number K002757  K043547  
Product Classification Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis - Product Code KRO
Product Biomet OSS Elliptical Proximal Femoral Trial 7 cm, right provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472124.

A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic surgery.
Code Information All lots. Lots 555720 and 989740.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
For Additional Information Contact
800-348-9500
Manufacturer Reason
for Recall		 The retaining ring may fall out of the instrument during surgery.
FDA Determined
Cause 2		 Process control
Action Distributors and consignees were notified by an Urgent Medical Device Recall Notice dated 5/19/09. Distributors and consignees were instructed to locate and remove the devices from circulation, carefully follow the instructions on the "FAX Back Response Form," and fax a copy of the Response Form to 574-372-1683 prior to return of the product. If the product has been further distributed, consignees must notify hospital personnel responsible for receiving recall notices of the action, via the enclosed "Dear Biomet Customer" notice. Consignees are responsible for the location and return of products to the firm. The letter stated that the instruments would be reworked and returned.
Quantity in Commerce 387 of all products
Distribution Worldwide Distribution -- USA, Australia, Belgium, Canada, Costa Rica, Finland, France, Germany, Mexico, New Zealand, Poland, South Wales, and Spain.
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.
510(K) Database 510(K)s with Product Code = KRO and Original Applicant = BIOMET, INC.
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