Recall Z-0941-2013— Synthes USA HQ, Inc.

Name: FDA recall Z-0941-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-11

Class II · Terminated

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-01-11, terminated 2015-08-31. It names one FDA 510(k) clearance: K082650. Product: Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.. Reason: The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts..

Recalling firm: Synthes USA HQ, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-01-11
Terminated: 2015-08-31
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K082650 — SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONALSynthes (Usa)·cleared 2008-11-18

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

Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

Reason for recall

The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.

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