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U.S. Department of Health and Human Services

Class 2 Device Recall Toe implant prosthesis

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  Class 2 Device Recall Toe implant prosthesis see related information
Date Initiated by Firm May 29, 2008
Date Posted September 18, 2008
Recall Status1 Terminated 3 on September 24, 2008
Recall Number Z-2228-2008
Recall Event ID 48693
510(K)Number k071243  
Product Classification Toe implant - Product Code KWD
Product Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03, 03-6000-04, OrthoPro LLC, Salt Lake City, UT Hemi is designed to supplement first metatarsal Phalangeal joint arthroplasty.
Code Information Lot numbers: OP-1628, OP-1620, OP-1550, OP-1549, OP-1545, OP-1525, OP-1524, OP-1523, OP-1522, OP-1521, OP-1520, OP-1519, OP-1426, OP-1425, OP-1424, OP-1423, OP-1422, OP-1421, OP-1419, OP-1420, and 07-0310.
Recalling Firm/
Manufacturer		 OrthoPro LLC
3450 Highland Dr Ste 303
Salt Lake City UT 84106-4369
For Additional Information Contact
801-746-0208
Manufacturer Reason
for Recall		 Labeling presented conflicting information as to whether device was sterile or not.
FDA Determined
Cause 2		 Labeling mix-ups
Action All sales agents were verbally notified on 05/29/2008 and told to locate and return all available affected implants. For assistance, contact OrthoPro at 1-801-746-0208.
Quantity in Commerce 210 units
Distribution AZ, CA, CO, FL, HI, IL, IN, MI, NY, OH, OR, PA, RI, TX, UT, VA, and WA.
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 = KWD and Original Applicant = ORTHOPRO LLC
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