FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
- Recall number
- Z-0097-2018
- Recalling firm
- Smith & Nephew, Inc.
- Product
- smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
- Status
- Open, Classified
- Initiated
- 2017-10-24
- Posted
- not on file
- Terminated
- not on file
- Reason
- A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.
- Root cause
- Employee error
- Action
- Smith & Nephew sent an Urgent Medical Device Recall Notice dated October 24, 2017, to all affected customers. The firm requested return of the product. Please follow the instructions on the attached Response Form. For further questions, please call (978) 749-1440.
- Quantity
- 17 units
- Distribution
- US Distribution - TN, IL, CT, MO, CA., and Internationally to Italy and Germany
- Lot, serial or model codes
- Lot number 16LM07111
- 510(k) numbers
- ["K040212"]
- PMA numbers
- not on file
- Product code
- JDS
- 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