FDA Medical Device Recalls (openFDA)
Warsaw Orthopedic, Inc.: Medtronic Sofamor Danek brand METRx System MD Procedure Kit; Ref 9560030.
- Recall number
- Z-0993-05
- Recalling firm
- Warsaw Orthopedic, Inc.
- Product
- Medtronic Sofamor Danek brand METRx System MD Procedure Kit; Ref 9560030.
- Status
- Terminated
- Initiated
- 2005-06-20
- Posted
- 2005-07-13
- Terminated
- 2006-02-08
- Reason
- The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
- Root cause
- Package design/selection
- Action
- Consignees were notified, via letter dated June 20, 2005, of the problem and to return all non-expired product.
- Quantity
- not on file
- Distribution
- Nationwide, Australia, Brazil, Canada, Chile, China, Dubai, Hong Kong, India, Korea, Mexico, Netherlands, South Africa and Taiwan.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K993021"]
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 1824199
- 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