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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 prosthesissee related information
Date Initiated by FirmMay 29, 2008
Date PostedSeptember 18, 2008
Recall Status1 Terminated 3 on September 24, 2008
Recall NumberZ-2228-2008
Recall Event ID 48693
510(K)NumberK071243 
Product Classification Toe implant - Product Code KWD
ProductMetal 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.
FEI Number 3005252592
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
ActionAll 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 Commerce210 units
DistributionAZ, CA, CO, FL, HI, IL, IN, MI, NY, OH, OR, PA, RI, TX, UT, VA, and WA.
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 = KWD
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