Z-2228-2008

Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03, 03-6000-04, OrthoPro LLC, Salt...

Name: Z-2228-2008 Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03, 03-6000-04, OrthoPro LLC, Salt...
Creator: OrthoPro LLC
Published: 2008-05-29
License: https://open.fda.gov/license/

Orthopro, LLC / initiated 2008-05-29 / Terminated / root cause: labeling and UDI

FDA source

OrthoPro LLC began a recall of 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... on 2008-05-29. The reason FDA records is "Labeling presented conflicting information as to whether device was sterile or not". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2228-2008
Status: Terminated
Initiated: 2008-05-29
Posted: 2008-09-18
Terminated: 2008-09-24
Recalling firm: Orthopro, LLC
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.
Product code: KWD Prosthesis, Toe, Hemi-, Phalangeal
Reason for recall: Labeling presented conflicting information as to whether device was sterile or not.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and 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.

Product code KWD

K071243Class IIMetal Hemi ImplantOrthopro, LLC / cleared 2007-05-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)