Recall Z-1820-2013— DePuy Orthopaedics, Inc.

Name: FDA recall Z-1820-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-11

Class I · Terminated

Class I FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2013-07-11, terminated 2014-07-10. It names one FDA 510(k) clearance: K041085. Product: LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.. Reason: The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads..

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class I
Status: Terminated
Initiated: 2013-07-11
Terminated: 2014-07-10
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K041085 — LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYDepuy, Inc.·cleared 2004-07-22

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

LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.

Reason for recall

The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads.

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