Recall Z-0884-2020— Brasseler USA I Lp

Name: FDA recall Z-0884-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-11

Class II · Terminated

Class II FDA medical device recall by Brasseler USA I Lp, initiated 2019-12-11, terminated 2021-02-12. It names one FDA 510(k) clearance: K945670. Product: Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.. Reason: 103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were incorrectly labeled as KM169-39-76 Single Diamond Threaded Steinmann Pins..

Recalling firm: Brasseler USA I Lp
Classification: Class II
Status: Terminated
Initiated: 2019-12-11
Terminated: 2021-02-12
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 KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.

Reason for recall

103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were incorrectly labeled as KM169-39-76 Single Diamond Threaded Steinmann Pins.

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