Recall Z-0707-2022— Brasseler USA, Medical L.L.C.

Name: FDA recall Z-0707-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-28

Class II · Terminated

Class II FDA medical device recall by Brasseler USA, Medical L.L.C., initiated 2022-01-28, terminated 2023-02-03. It names one FDA 510(k) clearance: K945670. Product: Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S. Reason: One lot of product was distributed in unsealed packaging.

Recalling firm: Brasseler USA, Medical L.L.C.
Classification: Class II
Status: Terminated
Initiated: 2022-01-28
Terminated: 2023-02-03
Firm location: Savannah, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K945670 — KIRSCHNER (K-WIRE), STEINMAN PINSBrasseler USA I, L.P.·cleared 1995-03-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

One lot of product was distributed in unsealed packaging

Data sourced from openFDA. This site is unofficial and independent of the FDA.