FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125 degree, (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, (6) REF 71675207, 10 MM X 18 CM, 130 degree, (7) REF 71675208, 11.5 MM X 18 CM, 130 degree, (8) REF 71675211, 11.5 MM X 20 CM, 130 degree, Smith & Nephew, Inc. Orthopedic fixation device.
- Recall number
- Z-1636-2014
- Recalling firm
- Smith & Nephew Inc
- Product
- TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125 degree, (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, (6) REF 71675207, 10 MM X 18 CM, 130 degree, (7) REF 71675208, 11.5 MM X 18 CM, 130 degree, (8) REF 71675211, 11.5 MM X 20 CM, 130 degree, Smith & Nephew, Inc. Orthopedic fixation device.
- Status
- Terminated
- Initiated
- 2014-04-04
- Posted
- 2014-05-20
- Terminated
- 2017-07-01
- Reason
- A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
- Root cause
- Process control
- Action
- The firm initiated the recall via an "Urgent - Product Recall 1st Notification - Urgent" letter and e-mail on 04/04/2014, identifying the product, explaining the problem, and the potential risk associated with using the product. Customers are to inspect their inventory, and locate and quarantine any affected product. Additionally, the Inventory Return Certification form should be completed and returned along with any affected product identified, once a Return Authorization number has been obtained from Smith & Nephew's Safety Affairs Department.
- Quantity
- 1,253 units total
- Distribution
- Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.
- Lot, serial or model codes
- TRIGEN INTERTAN NAIL: (1) REF 71675201, Lot Numbers: 13LT36305, 13LT36306, 13LT36547, 13LT36548, 13LT37009, 13LT37010, 13MT37347, 13MT37665, 13MT37667, 13MT37668, 14AT38179, 14AT38180, 14AT38181, 14T38182, 14AT38183, 14AT38189, 14AT38190 (2) REF 71675202, Lot Numbers: 13LT36308, 13LT36549, 13LT37011, 13MT37348, 14AT38750 (3) REF 71675203, Lot Numbers: 13KT36106, 13LT36596, 14AT38494 (4) REF 71675204, Lot Numbers: 13LT36597, 13LT37012, 14AT38495, 14AT38660 (5) REF 71675205, Lot Number 13LT36598 (6) REF 71675207, Lot Numbers: 13LT363089, 13LT36310, 13LT36599, 13LT37058, 13LT37059, 13LT37063, 13MT37264, 13MT37265, 13MT37266, 13MT37329, 13MT37349, 13MT37350, 13MT37669, 13MT37671, 13MT37672 (7) REF 71675208, Lot Numbers: 13LT36311, 13LT36312, 13LT36600, 13LT37060, 13LT37061, 13MT37351, 13MT37666, 13MT37963 (8) REF 71675211, Lot Number 13LT36313
- 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