FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
- Recall number
- Z-0944-2013
- Recalling firm
- Smith & Nephew Inc
- Product
- INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
- Status
- Terminated
- Initiated
- 2013-02-07
- Posted
- 2013-03-13
- Terminated
- 2016-01-11
- Reason
- 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.
- Root cause
- Labeling mix-ups
- Action
- Smith & Nephew sales representatives and Smith & Nephew international distributors were notified of problem and the recall via email on February 7, 2013. They were instructed to cease use and distribution of the product and quarantine for return. Non responding consignees were notified again on February 28, 2013 by email. Hospitals were notified by letter beginning on February 7, 2013. Smith & Nephew also contacted the surgeons who implanted the screws by letter the week of February 11th. For questions regarding this recall call 978-749-1330.
- Quantity
- 90 units
- Distribution
- Worldwide Distribution - USA including NM, TN, TX, NC, CA, MI, KY, MA, NJ, OH, and HI. Internationally to Canada, United Arab Emirates, Mexico, Argentina, Japan, and Chile.
- Lot, serial or model codes
- Batch Number 12JM17051
- 510(k) numbers
- ["K981529"]
- 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