Medical Device Recall: Z-0038-2015

FDA Recalls dataset · Firm: DePuy Orthopaedics, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2014-09-03 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0038-2015.

Recall Res Number
Z-0038-2015
Recalling Firm / Manufacturer
DePuy Orthopaedics, Inc.
FEI Number
1818910
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2014-09-03
Date Posted
2014-10-08
Date Terminated
2015-11-09
Product Code
LXH
Event Number
69104
Product Quantity
875 units
Product Description RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
Reason for Recall Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.
Action Details On February 25, 2013, DePuy Orthopaedics, Inc. issued a device correction for the specific lots of the RECLAIM Distal Reamer Extension impacted by this recall. The letter stated the reason for the recall and swap out. A subsequent letter outlined a formal swap-out process of the affected reamer extensions as part of the device correction strategy. Newly designed devices are now available. Questions about device swap-out information may be directed to Kim Earle, Recall Coordinator, 574-371-4917; and Surgeon questions may be directed to DePuy's Scientific Information Office at 1-888-554-2482.
Distribution Pattern Worldwide Distribution -- USA, including the states of ME, MD, PA, MA, FL, LA, IL, IA, OH, MN, TX, MT, WA, CA, HI, NV, AZ, KY, WI, CO, GA, MI, NC, VA, NY, TN, and IN; and, the countries of Canada, Australia, Austria, Belgium, Czech Republic, United Kingdom, France, Germany, Ireland, Israel, New Zealand, Norway, Poland, Slovenia, South Africa, Switzerland, and Chile.
Code Information / Serial Numbers J0111, J0211, J0411, J0611, J0911, J1211, NB12649, NB12650, NB12651, NB12652, NB12653, NB12654, NB12655, NB12656, NB23480, NB23481, NB3584, NB3586, NB3587, NB3588, NB3590, NB3591, NB5955, NB7894, NB8016, NB8017, NB8018, NB8019, NB8020, NB8021, NB8022, NB8023, 578910, 578913, R578910, R578912, R578913, 582631, and  592125.

Related Establishments / Registrations

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