FDA Medical Device Recalls (openFDA)
MicroPort Orthopedics Inc.: PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
- Recall number
- Z-1225-2022
- Recalling firm
- MicroPort Orthopedics Inc.
- Product
- PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
- Status
- Terminated
- Initiated
- 2022-05-04
- Posted
- not on file
- Terminated
- 2024-01-16
- Reason
- One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.
- Root cause
- Process change control
- Action
- The firm sent out a recall notification to the distributors on 05/04/2022 via email. Phone calls were also made to the distributors. Additionally, the US field communication letter was mailed to the surgeon and facility in regard to the one case of implantation on May 10, 2022. The consignee letter informed the consignee to cease use and distribution of the affected product, check inventory for affected product, complete the response form, return affected product and notify affected consignees. The field surgeon letter and hospital letter informs the consignee to cease use and distribution of the affected product, monitor patients per normal protocol, return affected product and sign and return the response form.
- Quantity
- 8 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, IN, MO, CA and the country of Canada.
- Lot, serial or model codes
- Catalog Number(s): PHAPCLS7; Lot Number(s): 1903727; Expiration Date: 11/24/2029; UDI/DI Number: 00192629112773
- 510(k) numbers
- ["K123434"]
- PMA numbers
- not on file
- Product code
- JDI
- Firm FEI
- 3010536692
- Firm city
- Arlington
- Firm state
- TN
- 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