FDAClass IIMarch 9, 2022

Brasseler USA recall

Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S

Why was Brasseler USA recalled?

One lot of product was distributed in unsealed packaging

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI (01)00887919491033(17)260719(10)NV1MX Lot Code NV1MX

Product
Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
Recalling firm
Brasseler USA, Medical L.L.C.
Quantity
231 units
Distribution
US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA IL, ID.
Recall date
March 9, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls