FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile, Zimmer GmbH, Winterthur, Switzerland; REF 02.02631.233. The device is used in orthopedic trauma surgeries for stabilization of tibial bone fractures.
- Recall number
- Z-1261-2009
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile, Zimmer GmbH, Winterthur, Switzerland; REF 02.02631.233. The device is used in orthopedic trauma surgeries for stabilization of tibial bone fractures.
- Status
- Terminated
- Initiated
- 2009-03-23
- Posted
- 2009-05-18
- Terminated
- 2009-10-23
- Reason
- The package is labeled as containing 330 mm length nails, but actually contains 300 mm length nails.
- Root cause
- Other
- Action
- Distributors were initially notified by phone on March 23, 2009. Distributors and user accounts were notified by an "Urgent: Device Recall" letter dated March 31, 2009. The letter described the affected product, reason for recall, risks to health, other information and actions for customers. Customers were instructed to quarantine recalled product and to return it to the Zimmer Distribution Center. For questions about the recall, contact Zimmer, Inc. at 1-800-613-6131.
- Quantity
- 32
- Distribution
- Worldwide Distribution -- US (states of Florida, Missouri, New Jersey, New York, Ohio, Oklahoma and Texas) and countries of Austria, Japan, Korea and Germany.
- Lot, serial or model codes
- Lot Number 2385866.
- 510(k) numbers
- K043270
- 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