FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705
- Recall number
- Z-1243-2017
- Recalling firm
- Smith & Nephew, Inc.
- Product
- Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705
- Status
- Terminated
- Initiated
- 2017-02-02
- Posted
- not on file
- Terminated
- 2019-09-20
- Reason
- The single use devices are provided sterile and do not have an expiration date on the label.
- Root cause
- Labeling Change Control
- Action
- Smith & Nephew, Inc. initiated recall by letter on 2/2/17 advising of the problem, requesting inspection of inventory and return of product. Contact Smith & Nephews Field Actions Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to return.
- Quantity
- 3462
- Distribution
- Nationwide Foreign: Brazil, Canada, Chile , China, Denmark, Hong Kong, India, Mexico, Peru, Singapore, Venezuela
- Lot, serial or model codes
- Batch Numbers: 50525150 50386077 50261802 50197616 50178740 50171398 50158656 50138050 50121538 50103379 50089298 50082582 50061131
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HAB
- 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