Recall Z-1745-2013— Synthes USA HQ, Inc.

Name: FDA recall Z-1745-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-31

Class II · Terminated

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-05-31, terminated 2015-08-31. It names one FDA 510(k) clearance: K010690. Product: Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps.. Reason: Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however there.

Recalling firm: Synthes USA HQ, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-05-31
Terminated: 2015-08-31
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K010690 — SYNTHES TITANIUM MULTI-VECTOR DISTRACTORSynthes (Usa)·cleared 2001-05-18

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

Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps.

Reason for recall

Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however there

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