Brasseler USA, K-WIRE, Double Trocar Smooth, REF… recallZ-0707-2022 · Brasseler USA, Medical L.L.C. · initiated Jan 28, 2022
Terminated
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 Brasseler USA, Medical L.L.C. 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 lot of product was distributed in unsealed packaging
FDA root cause category: Under Investigation by firm
What the company is doing
The firm initiated the recall by telephone on 01/28/2022 and followed with a letter delivered by email. The letter explained the issue and requested the consignee set the affected product aside to be returned to the recalling firm.
Recall details
- Recall number
- Z-0707-2022
- Status
- Terminated
- Initiated by the company
- Jan 28, 2022
- Recalling firm
- Brasseler USA, Medical L.L.C.
- Quantity
- 231 units
- Product code
- HTY
- FDA submissions
- K945670
- Distribution
- US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA IL, ID.
Product description
Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
Code information (models, lots, serial numbers)
UDI (01)00887919491033(17)260719(10)NV1MX Lot Code NV1MX
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Brasseler USA 5007972M0Peter Brasseler Holdings, LLC · PIN, FIXATION, SMOOTH1 recall0 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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