FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
- Recall number
- Z-2635-2016
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
- Status
- Terminated
- Initiated
- 2016-07-18
- Posted
- not on file
- Terminated
- 2016-11-22
- Reason
- The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
- Root cause
- Employee error
- Action
- On 07/18/2016, the firm initiated the correction by verbally notifying (by visit and telephone) three of four (3 of 4) implanting surgeons; the fourth implanting surgeon was verbally notified on 07/25/2016. The firm followed with a letter to all four (4) surgeons on 07/28/2016. Medtronic recommended that the condition of the patients receiving the subject part be assessed for any indications of premature failure during normal post-operative follow-up visits.
- Quantity
- 3 units
- Distribution
- AR, MN,MA
- Lot, serial or model codes
- P239166, P239167.
- 510(k) numbers
- ["K150496"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1000477302
- Firm city
- Memphis
- Firm state
- TN
- 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