TRIGEN recallZ-1806-2025 · Smith & Nephew, Inc. · initiated Mar 18, 2025
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
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
FDA root cause category: Process control
What the company is doing
On 3/18/2025, recall notices were mailed and emailed to customers who were asked to do the following: 1) Inspect your inventory and locate any affected devices and quarantine them. 2) If you are a sales rep, district office, or distributor, you must notify your customers of the field action and ensure that the required actions are complete. 3) Complete and return the notice response section via email to [email protected] If you have any questions email the firm at the email address above.
Recall details
- Recall number
- Z-1806-2025
- Status
- Open, Classified
- Initiated by the company
- Mar 18, 2025
- Posted by the FDA
- May 19, 2025
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 75
- Product code
- HSB
- FDA submissions
- K092748, K210980
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, NH, TX, CA, OH, NY, AL, IA, MA, NV, MO, WA, LA, TN, NC, KY, NM, NJ, AZ and the country of ZA.
Product description
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Code information (models, lots, serial numbers)
UDI-DI: 00885556132975. Lot: 24CT81426. Expiration: 25-Mar-2034
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TRIGEN 71642690Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall3 reports
Product lines
Other devices under the same FDA submission
149 devices cleared under K092748, K210980 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- TRIGEN 71647336Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 recalls1 report
- 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
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.
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