CLASS II Device recall · Reported 9 Mar 2022 · FDA Enforcement Report
Brasseler USA, K-wire, Double Trocar Smooth recalled
Brasseler USA, Medical is recalling Brasseler USA, K-wire, Double Trocar Smooth, distributed nationwide in the US. The recall was initiated on 28 Jan 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0707-2022
- FDA event ID
- 89555
- Recalling firm
- Brasseler USA, Medical, Savannah, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jan 2022
- FDA classified
- 1 Mar 2022
- Reported
- 9 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 28 Jan 2022 | Recall initiated by company | |
| 1 Mar 2022 | Classified by FDA | +32 days |
| 9 Mar 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One lot of product was distributed in unsealed packaging
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
Where it was distributed
US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA IL, ID.
Nationwide ArizonaCaliforniaFloridaIdahoIllinoisMichiganPennsylvaniaSouth CarolinaTennesseeTexas
Questions about this recall
Is Brasseler USA, K-wire, Double Trocar Smooth recalled?
Yes. Brasseler USA, Medical recalled Brasseler USA, K-wire, Double Trocar Smooth on 28 Jan 2022. The recall is Class II and its status is Terminated. Recall number Z-0707-2022.
Why was it recalled?
One lot of product was distributed in unsealed packaging
Which lots are affected?
UDI (01)00887919491033(17)260719(10)NV1MX Lot Code NV1MX
Where was it sold?
US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA IL, ID.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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