FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48 degrees, 9/10 mm diameter, nonsterile; REF 4309-18-10, Catalog no. 00-4309-018-10.
- Recall number
- Z-0210-2007
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48 degrees, 9/10 mm diameter, nonsterile; REF 4309-18-10, Catalog no. 00-4309-018-10.
- Status
- Terminated
- Initiated
- 2006-10-19
- Posted
- 2006-11-22
- Terminated
- 2007-12-05
- Reason
- The instrument may fracture at the threaded end during intramedullary trialing and leave the distal pilot trial in the humeral canal.
- Root cause
- Other
- Action
- The firm''s sales force was notified via recall letter dated 10/19/06 to secure product from customer accounts and to return it to Zimmer.
- Quantity
- 50
- Distribution
- Nationwide and Australia.
- Lot, serial or model codes
- Lots 60457716 and 60492624.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWT
- 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