Recall Z-0380-2014— Synthes USA HQ, Inc.

Name: FDA recall Z-0380-2014
Creator: U.S. Food and Drug Administration
Published: 2013-07-31

Class II · Terminated

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-07-31, terminated 2016-08-18. It names one FDA 510(k) clearance: K063049. Product: 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.. Reason: Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw..

Recalling firm: Synthes USA HQ, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-07-31
Terminated: 2016-08-18
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K063049 — SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEMSynthes (Usa)·cleared 2006-12-18

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

2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.

Reason for recall

Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw.

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