TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY:… recallZ-1132-2013 · Smith & Nephew Inc · initiated Mar 6, 2013
Class II Terminated All recalls posted in April 2013
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
One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).
FDA root cause category: Process control
What the company is doing
Smith & Nephew sent an Urgent Product Recall Notification letter dated March 6, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease use and distribution of the affected product and quarantine for return. Non-responding consignees were notified again on March 15, 2013, by email. Surgeons were to be notified by letter beginning on March 20, 2013. For questions regarding this recall call 978-749-1330.
Recall details
- Recall number
- Z-1132-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 6, 2013
- Posted by the FDA
- Apr 17, 2013
- Recalling firm
- Smith & Nephew Inc
- Quantity
- 23 units
- Product code
- HSB
- FDA submissions
- K111025
- Distribution
- Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.
Product description
TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery
Code information (models, lots, serial numbers)
Lot Number 12FM12182
Other devices under the same FDA submission
21 devices cleared under K111025 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- TRIGEN 71645030Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES12 reports
- TRIGEN 71645035Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES11 reports
- TRIGEN 71645040Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES10 reports
- TRIGEN 71645027Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES9 reports
- TRIGEN 71645045Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- TRIGEN 71645037Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- TRIGEN 71645050Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- TRIGEN 71645065Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- TRIGEN 71645025Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- TRIGEN 71645032Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- TRIGEN 71645055Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- TRIGEN 71645060Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
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 18, 2026. Text above is shown as published by the FDA.
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