FDA Medical Device Recalls (openFDA)
Zimmer Austin, Inc: MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer Austin, Inc., Austin, Texas 78717
- Recall number
- Z-0539-05
- Recalling firm
- Zimmer Austin, Inc
- Product
- MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer Austin, Inc., Austin, Texas 78717
- Status
- Terminated
- Initiated
- 2004-12-17
- Posted
- 2005-02-15
- Terminated
- 2007-11-27
- Reason
- Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications.
- Root cause
- Other
- Action
- The firm initiated the recall via letter on December 17, 2004. The firm''s letter requests the return of all recalled product.
- Quantity
- 121 units
- Distribution
- The product was distributed in AZ, CA, NY, IL, FL, MD, OH, MI, WI, MO, TX and to Canada and Portugal
- Lot, serial or model codes
- Catalog Numbers: 5000-50-100 and 5000-50-200; Lot Numbers: 1529444, 1536181, 1538936, 1538937, 1542189, 1568350, 1568351, 1569597, 1596886, 1596890, 1601839, 1601841, 1610470, 1616609, and 1617691
- 510(k) numbers
- ["K013031"]
- PMA numbers
- not on file
- Product code
- KRO
- Firm FEI
- 2935620
- Firm city
- Austin
- Firm state
- TX
- 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