FDA Medical Device Recalls (openFDA)
Power Surgical Solutions: Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas
- Recall number
- Z-0213-05
- Recalling firm
- Power Surgical Solutions
- Product
- Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas
- Status
- Terminated
- Initiated
- 2004-11-03
- Posted
- 2004-11-20
- Terminated
- 2005-11-03
- Reason
- Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke).
- Root cause
- Other
- Action
- The firm initiated the recall by letter on November 3, 2004 asking consignees to return unused units.
- Quantity
- 12,286 cases of 4 units per case
- Distribution
- Product was shipped nationwide and to the following foreign countries: Australia, Canada, Hong Kong, Japan, Netherlands, Columbia, Chile, and Venezuela.
- Lot, serial or model codes
- A5972-V01; A5982-V01; A5991-V01; A5992-V01; A6308-V01through A6327-V01; A6666-V01 through A6684-V01; A6686-V01 through A6691-V01; A6919-V01 through A6934-V01; A7184-V01 through A7188-V01; A7194-V01through A7198-V01; A7495-V01 through A7501-V01; A7520-V01; A7521-V01; and A7525-V01
- 510(k) numbers
- ["K020069"]
- PMA numbers
- not on file
- Product code
- HBB
- Firm FEI
- 1625507
- Firm city
- Fort Worth
- 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