Recall Z-0415-2014— DePuy Orthopaedics, Inc.

Name: FDA recall Z-0415-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-18

Class II · Terminated

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2013-11-18, terminated 2015-02-24. It names 2 FDA 510(k) clearances: K033272, K032151. Product: SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.. Reason: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient..

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-18
Terminated: 2015-02-24
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K033272 — DEPUY SIGMA TIBIAL INSERTSDePuy Orthopaedics, Inc.·cleared 2004-02-05
K032151 — DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYSDepuy, Inc.·cleared 2003-09-26

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

SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

Reason for recall

DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.

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