FDA Medical Device Recalls (openFDA)
OrthoPro LLC: 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.
- Recall number
- Z-2228-2008
- 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.
- Status
- Terminated
- Initiated
- 2008-05-29
- Posted
- 2008-09-18
- Terminated
- 2008-09-24
- Reason
- Labeling presented conflicting information as to whether device was sterile or not.
- 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
- 210 units
- Distribution
- AZ, CA, CO, FL, HI, IL, IN, MI, NY, OH, OR, PA, RI, TX, UT, VA, and WA.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K071243"]
- PMA numbers
- not on file
- Product code
- KWD
- Firm FEI
- 3005252592
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28