FDA Medical Device Recalls (openFDA)
DePuy Orthopaedics, Inc.: 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.
- Recall number
- Z-0038-2015
- 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.
- Status
- Terminated
- Initiated
- 2014-09-03
- Posted
- 2014-10-08
- Terminated
- 2015-11-09
- Reason
- Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28