FDA Medical Device Recalls (openFDA)
Zimmer Inc.: M/DN Intramedullary Fixation Humeral Nail
- Recall number
- Z-1004-04
- Recalling firm
- Zimmer Inc.
- Product
- M/DN Intramedullary Fixation Humeral Nail
- Status
- Terminated
- Initiated
- 2004-03-16
- Posted
- 2004-07-20
- Terminated
- 2004-07-02
- Reason
- One and possibly more units in the lot have the proximal angled hole oriented 180 degrees reversed from the required orientation.
- Root cause
- Other
- Action
- Units were distributed to twelve (12) consignees in the US and seven (7) foreign consignees (China, Japan, Korea, El Salvador, Singapore, Taiwan and UK)
- Quantity
- 33 units
- Distribution
- not on file
- Lot, serial or model codes
- Catalog no. 00-2254-195-09 Lot # 20118000
- 510(k) numbers
- ["K965098"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- 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