TRIGEN recallZ-2443-2023 · Smith & Nephew, Inc. · initiated Jul 24, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
FDA root cause category: Process control
What the company is doing
Smith & Nephew issued an Urgent Medical Device Recall Notice on 07/24/2023. The notice explained the problem with the product, the potential risk, and requested the consignees locate and quarantine the affected product for return. Sales reps, district offices, or distributors were directed to notify their customers and ensure that the required actions were complete. The firm is seeking return of the affected product.
Recall details
- Recall number
- Z-2443-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 24, 2023
- Posted by the FDA
- Aug 22, 2023
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 30 units
- Product code
- HSB
- FDA submissions
- K040462, K210980
- Distribution
- US, AE, CA, DE, ES, GB, MX, PA, PL
Product description
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
Code information (models, lots, serial numbers)
UDI/DI 03596010500922, Batch Number 21KSM0598
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TRIGEN 71647336Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 recalls1 report
Product lines
Other devices under the same FDA submission
130 devices cleared under K040462, K210980 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- TRIGEN 71642690Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall3 reports
- TRIGEN 71676627Smith & Nephew, Inc. · NAIL, FIXATION, BONE1 recall2 reports
- TRIGEN 71760816Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall2 reports
- TRIGEN 71676628Smith & Nephew, Inc. · NAIL, FIXATION, BONE1 recall0 reports
- TRIGEN 71677100Smith & Nephew, Inc. · NAIL, FIXATION, BONE20 reports
- TRIGEN 71677095Smith & Nephew, Inc. · NAIL, FIXATION, BONE18 reports
- TRIGEN 71675202Smith & Nephew, Inc. · NAIL, FIXATION, BONE15 reports
- INTERTAN 71934479Smith & Nephew, Inc. · NAIL, FIXATION, BONE12 reports
- TRIGEN 71645030Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES12 reports
- TRIGEN 71701016LSmith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES12 reports
- TRIGEN 71645035Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES11 reports
- TRIGEN 71677090Smith & Nephew, Inc. · NAIL, FIXATION, BONE11 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92767).
- Z-2444-2023 · Open, ClassifiedTRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page