FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: 6.5MMX165MM CANNULATED SCREW
- Recall number
- Z-0143-2022
- Recalling firm
- Smith & Nephew, Inc.
- Product
- 6.5MMX165MM CANNULATED SCREW
- Status
- Terminated
- Initiated
- 2021-09-20
- Posted
- not on file
- Terminated
- 2023-03-24
- Reason
- The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.
- Root cause
- Process control
- Action
- Smith & Nephew issued a customer letter via email dated September 20, 2021. Consignees are asked to inspect inventory and locate any devices from the listed product and batch numbers enclosed with the Urgent Medical Device Recall Notice, and quarantine them immediately. Consignees must complete the enclosed response form, sign and send to FieldActions@smith-nephew.com. Response form shall be completed even if there is no impacted product on hand.
- Quantity
- 5 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of OK, TN and the country of Canada.
- Lot, serial or model codes
- Model 71106365S; Lot 20GT39417
- 510(k) numbers
- ["K060736"]
- PMA numbers
- not on file
- Product code
- HWC
- 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