Z-0038-2015Class II

RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal...

Name: Z-0038-2015 RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal...
Creator: DePuy Orthopaedics, Inc.
Published: 2014-09-03
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2014-09-03 / Terminated / root cause: design

FDA source

DePuy Orthopaedics, Inc. began a recall of 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... on 2014-09-03. FDA classified it as Class II and gives the reason as "Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0038-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-03
Posted: 2014-10-08
Terminated: 2015-11-09
Recalling firm: Depuy Orthopaedics Inc.
Product: 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.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 875 units
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0038-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0038-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-07

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)