Recall Z-0167-2016— Synthes (USA) Products LLC

Name: FDA recall Z-0167-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-06

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2015-10-06, terminated 2016-07-15. It names one FDA 510(k) clearance: K063049. Product: 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.. Reason: Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2015-10-06
Terminated: 2016-07-15
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

2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.

Reason for recall

Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.

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