FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
- Recall number
- Z-0406-2018
- Recalling firm
- Smith & Nephew, Inc.
- Product
- Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
- Status
- Terminated
- Initiated
- 2017-10-23
- Posted
- not on file
- Terminated
- 2018-08-24
- Reason
- The expiration date provided on the label is incorrect.
- Root cause
- Process change control
- Action
- The firm initiated their recall by an Urgent Medical Device Recall Notice on 10/23/2017. The letter identified the affected device and the reason for the recall, as well as the potential risk. The firm instructed users to please inspect their inventory and locate any unused devices from the list of product and batch numbers provided in the Notice. Affected devices must be quarantined immediately. Distributors, must notify their customers of the field action and ensure that the actions are carried out. The attached form should be completed and returned. Questions or concerns can be directed to FieldActions@smith-nephew.com.
- Quantity
- 9 units
- Distribution
- Worldwide Distribution -- US, to the states of TN and NJ; and, Australia.
- Lot, serial or model codes
- Lot Numbers: 14HSY0006R, 15MSY0005R, 15KSY0023R, 09FSY0003R, and 12HSY0040R.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MDM
- Firm FEI
- 1020279
- 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