Recall Z-2212-2014— Biomet, Inc.

Name: FDA recall Z-2212-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-23

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2014-06-23, terminated 2015-07-14. It names 2 FDA 510(k) clearances: K052248, K041081. Product: Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581. Reason: The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before it becomes stuck..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-06-23
Terminated: 2015-07-14
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K052248 — DORSAL NAIL PLATE, ANATOMICALHand Innovations, LLC·cleared 2005-09-14
K041081 — FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRESHand Innovations, Inc.·cleared 2004-07-01

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

Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581

Reason for recall

The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before it becomes stuck.

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