Recall Z-2521-2018— DePuy Orthopaedics, Inc.

Name: FDA recall Z-2521-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-21

Class II · Terminated

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2018-06-21, terminated 2020-04-06. It names 2 FDA 510(k) clearances: K123991, K042992. Product: CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511. Reason: Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures..

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-06-21
Terminated: 2020-04-06
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K123991 — DEPUY CORAIL AMT HIP PROSTHESISDepuy France S.A.S.·cleared 2013-09-16
K042992 — CORAIL AMT HIP PROSTHESISDePuy Orthopaedics, Inc.·cleared 2005-02-11

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

CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511

Reason for recall

Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.

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