Z-0707-2022Class II

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

Name: Z-0707-2022 Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
Creator: Brasseler USA, Medical L.L.C.
Published: 2022-01-28
License: https://open.fda.gov/license/

Brasseler USA I, L.P. / initiated 2022-01-28 / Terminated / root cause: packaging

FDA source

Brasseler USA, Medical L.L.C. began a recall of Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S on 2022-01-28. FDA classified it as Class II and gives the reason as "One lot of product was distributed in unsealed packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0707-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-28
Posted: 2022-03-01
Terminated: 2023-02-03
Recalling firm: Brasseler USA I, L.P.
Product: Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
Product code: HTY Pin, Fixation, Smooth
Reason for recall: One lot of product was distributed in unsealed packaging
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 231 units
Distribution: US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA IL, ID.
Product codes and lots: UDI (01)00887919491033(17)260719(10)NV1MX Lot Code NV1MX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0707-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0707-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-03-01

Product code HTY

K945670Class IIKirschner (K-Wire), Steinman PinsBrasseler USA I, L.P. / cleared 1995-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)