FDA Medical Device Recalls (openFDA)
Portland Orthopaedics Pty, Ltd.: Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-051. Product is used for Orthopedic surgery.
- Recall number
- Z-1963-2008
- Recalling firm
- Portland Orthopaedics Pty, Ltd.
- Product
- Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-051. Product is used for Orthopedic surgery.
- Status
- Terminated
- Initiated
- 2008-01-11
- Posted
- 2008-09-18
- Terminated
- 2009-11-12
- Reason
- Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- Root cause
- Device Design
- Action
- Stocks were pulled from U.S. consignees on or before 1/11/08. Consignee and implanting surgeon letters dated 6/20/08 were sent advising of the issue and recommending patient monitoring. For assistance, contact Portland Orthopaedics at 1-810-329-3348.
- Quantity
- 2403 of all products
- Distribution
- Nationwide.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K032641","K992815"]
- PMA numbers
- not on file
- Product code
- MEH
- Firm FEI
- 3003755751
- Firm city
- Kogarah
- Firm state
- not on file
- Firm country
- Australia
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