TRIGEN recallZ-1133-2022 · Smith & Nephew Orthopaedics GmbH · initiated Apr 22, 2022
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 Orthopaedics GmbH 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
Right nails were anodized, marked, and labelled as left nails and vice versa
FDA root cause category: Under Investigation by firm
What the company is doing
The firm sent out a recall notification letter via email and overnight mail on 04/22/2022. The letter instructs the consignee to check inventory, return affected product, and complete the response form. Distributors were informed to notify their customers of the field action.
Recall details
- Recall number
- Z-1133-2022
- Status
- Open, Classified
- Initiated by the company
- Apr 22, 2022
- Recalling firm
- Smith & Nephew Orthopaedics GmbH
- Quantity
- 17 units
- Product code
- JDS
- FDA submissions
- K040212
- Distribution
- Distributed nationwide to GA, OH, IN, TX, CO, MO, TN, CA, NC, PA and internationally to Canada, Australia.
Product description
INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
Code information (models, lots, serial numbers)
Product number: 71676627 (DI: 00885556131633), Batch Number: 21LT56988; 71676628 (DI: 00885556040027), Batch number: 21LT56989
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- TRIGEN 71676627Smith & Nephew, Inc. · NAIL, FIXATION, BONE1 recall2 reports
- TRIGEN 71676628Smith & Nephew, Inc. · NAIL, FIXATION, BONE1 recall0 reports
Product lines
Other devices under the same FDA submission
82 devices cleared under K040212 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- TRIGEN 71675383Smith & Nephew, Inc. · NAIL, FIXATION, BONE29 reports
- TRIGEN 71677100Smith & Nephew, Inc. · NAIL, FIXATION, BONE20 reports
- TRIGEN 71675385Smith & Nephew, Inc. · NAIL, FIXATION, BONE18 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 71677090Smith & Nephew, Inc. · NAIL, FIXATION, BONE11 reports
- TRIGEN 71675384Smith & Nephew, Inc. · NAIL, FIXATION, BONE10 reports
- TRIGEN 71675501Smith & Nephew, Inc. · NAIL, FIXATION, BONE8 reports
- TRIGEN 71675208Smith & Nephew, Inc. · NAIL, FIXATION, BONE8 reports
- TRIGEN 71677085Smith & Nephew, Inc. · NAIL, FIXATION, BONE8 reports
- TRIGEN 71675386Smith & Nephew, Inc. · NAIL, FIXATION, BONE7 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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