Recall Z-2228-2008

OrthoPro LLC · initiated May 29, 2008

Terminated

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.

Codes / lots: 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.

Reason for recall

Labeling presented conflicting information as to whether device was sterile or not.

FDA-determined cause: Labeling mix-ups

Action taken

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.

Details

Recall number
Z-2228-2008
Initiated
May 29, 2008
Posted by FDA
September 18, 2008
Terminated
September 24, 2008
Product code
KWD – Prosthesis, Toe, Hemi-, Phalangeal
Quantity
210 units
Distribution
AZ, CA, CO, FL, HI, IL, IN, MI, NY, OH, OR, PA, RI, TX, UT, VA, and WA.
Recalling firm
OrthoPro LLC, Salt Lake City, UT

Official FDA recall record